QUALITY TECH SERVICES, LLC

Contract manufacturer · Bloomington, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2010Product codes first listed, by year (tallest: 33)2026

FDA registration: 3003477135 (openFDA record; or search FDA's registration database)
FEI number: 3003477135
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: QUALITY TECH SERVICES, LLC (FDA owner/operator no. 9047880)
Registered address: 10525 Hampshire Ave. S., Bloomington, MN 55438
Contract listings: 312 device listings, 149 product codes, first listed Sep 20, 2010
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
BSR	Stylet, Tracheal Tube	Class I	Anesthesiology	Contract manufacturing	Sep 13, 2022
CBK	Ventilator, Continuous, Facility Use	Class II	Anesthesiology	Contract manufacturing	Dec 26, 2013
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Class II	Immunology	Contract manufacturing	Oct 31, 2016
DWS	Instruments, Surgical, Cardiovascular	Class I	Cardiovascular	Contract manufacturing	Oct 5, 2012
DZE	Implant, Endosseous, Root-Form	Class II	Dental	Contract manufacturing	Oct 5, 2012
ELZ	Crown, Preformed	Class I	Dental	Contract manufacturing	Jul 8, 2021
ENW	Catheter, Nasopharyngeal	Class I	Ear, nose and throat	Contract manufacturing	Jan 11, 2015
ETN	Stimulator, Nerve	Class II	Ear, nose and throat	Contract manufacturing	Dec 9, 2024
EZL	Catheter, Retention Type, Balloon	Class II	Gastroenterology and urology	Contract manufacturing	Jan 5, 2013
EZW	Stimulator, Electrical, Implantable, For Incontinence	Class III	Gastroenterology and urology	Contract manufacturing	Dec 10, 2024
FGY	Cannula, Injection	Class I	General and plastic surgery	Contract manufacturing	Jan 11, 2015
FMF	Syringe, Piston	Class II	General hospital	Contract manufacturing	Jan 11, 2015
FQH	Lavage, Jet	Class II	General hospital	Contract manufacturing	Nov 25, 2012
FQO	Table, Operating-Room, Ac-Powered	Class I	General and plastic surgery	Contract manufacturing	Dec 9, 2024
FRO	Dressing, Wound, Drug	Unclassified	General and plastic surgery	Contract manufacturing	Oct 28, 2016
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 11, 2015
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Oct 27, 2016
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract manufacturing	Apr 9, 2014
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 2013
GDZ	Handle, Scalpel	Class I	General and plastic surgery	Contract manufacturing	Oct 23, 2012
GES	Blade, Scalpel	Class I	General and plastic surgery	Contract manufacturing	Dec 19, 2024
GEX	Powered Laser Surgical Instrument	Class II	General and plastic surgery	Contract manufacturing	Nov 25, 2012
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract manufacturing	Nov 28, 2017
GFG	Bit, Surgical	Class I	General and plastic surgery	Contract manufacturing	Oct 27, 2016
GFI	Osteotome, Manual	Class I	General and plastic surgery	Contract manufacturing	Nov 28, 2017
GWO	Plate, Cranioplasty, Preformed, Alterable	Class II	Neurology	Contract manufacturing	Nov 17, 2015
GXD	Generator, Lesion, Radiofrequency	Class II	Neurology	Contract manufacturing	Oct 24, 2017
GXI	Probe, Radiofrequency Lesion	Class II	Neurology	Contract manufacturing	Oct 24, 2017
GXR	Cover, Burr Hole	Class II	Neurology	Contract manufacturing	Dec 15, 2012
GXZ	Electrode, Needle	Class II	Neurology	Contract manufacturing	Dec 9, 2024
GYK	Instrument, Shunt System Implantation	Class I	Neurology	Contract manufacturing	Dec 4, 2017
HAO	Instrument, Surgical, Non-Powered	Class I	Neurology	Contract manufacturing	Dec 9, 2024
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Oct 5, 2012
HBW	Fastener, Plate, Cranioplasty	Class II	Neurology	Contract manufacturing	Nov 17, 2015
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 26, 2013
HRX	Arthroscope	Class II	Orthopedic	Contract manufacturing	Nov 4, 2015
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 25, 2012
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Nov 25, 2012
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 26, 2014
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 3, 2015
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 25, 2012
HTE	Elevator	Class I	General and plastic surgery	Contract manufacturing	Oct 27, 2016
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Oct 27, 2016
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Jan 11, 2015
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Oct 31, 2016
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Oct 27, 2016
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Sep 20, 2010
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Dec 2, 2015
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Oct 27, 2016
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Dec 10, 2018
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Oct 5, 2012
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 2013
HWM	Osteotome	Class I	General and plastic surgery	Contract manufacturing	Nov 28, 2017
HWT	Template	Class I	Orthopedic	Contract manufacturing	Dec 29, 2014
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Dec 10, 2024
HXI	Passer, Wire, Orthopedic	Class I	Orthopedic	Contract manufacturing	Dec 27, 2013
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Nov 29, 2017
HXR	Spatula, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Nov 25, 2015
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Oct 27, 2016
IKE	Transducer, Miniature Pressure	Class I	Physical medicine	Contract manufacturing	Jan 11, 2015
IYE	Accelerator, Linear, Medical	Class II	Radiology	Contract manufacturing	Nov 16, 2015
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Class II	Radiology	Contract manufacturing	Nov 16, 2015
JAK	System, X-Ray, Tomography, Computed	Class II	Radiology	Contract manufacturing	Jan 11, 2015
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Nov 25, 2015
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Dec 26, 2013
JDZ	Mixer, Cement, For Clinical Use	Class I	Orthopedic	Contract manufacturing	Nov 6, 2018
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Dec 9, 2012
JWJ	Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	Class II	Orthopedic	Contract manufacturing	Dec 9, 2024
JXG	Shunt, Central Nervous System And Components	Class II	Neurology	Contract manufacturing	Nov 25, 2012
KCJ	Applicator, Ent	Class I	Ear, nose and throat	Contract manufacturing	Nov 25, 2012
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General hospital	Contract manufacturing	May 2, 2017
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract manufacturing	Dec 31, 2018
KIH	Dispenser, Cement	Class I	Orthopedic	Contract manufacturing	Apr 9, 2014
KPS	System, Tomography, Computed, Emission	Class II	Radiology	Contract manufacturing	Oct 5, 2012
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Dec 3, 2015
KTI	Bronchoscope Accessory	Class II	Ear, nose and throat	Contract manufacturing	Oct 28, 2016
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Class II	Orthopedic	Contract manufacturing	Nov 25, 2012
KWH	Prosthesis, Toe, Constrained, Polymer	Class II	Orthopedic	Contract manufacturing	Nov 25, 2012
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Mar 26, 2014
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Dec 8, 2012
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Dec 22, 2012
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Mar 26, 2014
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Oct 23, 2015
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Class II	Orthopedic	Contract manufacturing	Mar 26, 2014
KYI	Prosthesis, Wrist, Carpal Trapezium	Class II	Orthopedic	Contract manufacturing	Mar 26, 2014
KYJ	Prosthesis, Finger, Constrained, Polymer	Class II	Orthopedic	Contract manufacturing	Nov 26, 2018
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Class III	Neurology	Contract manufacturing	Nov 22, 2017
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	Oct 28, 2016
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 9, 2012
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 9, 2012
LXB	Hearing Aid, Bone Conduction	Class II	Ear, nose and throat	Contract manufacturing	Jan 11, 2015
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Sep 20, 2010
LXN	Probe, Test, Heart-Valve	Class I	Cardiovascular	Contract manufacturing	Dec 9, 2012
LYA	Splint, Intranasal Septal	Class I	Ear, nose and throat	Contract manufacturing	Dec 11, 2017
LZJ	Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained	Unclassified	Orthopedic	Contract manufacturing	Mar 31, 2014
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Oct 23, 2015
LZP	Aid, Surgical, Viscoelastic	Class III	Ophthalmic	Contract manufacturing	Dec 9, 2024
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Sep 6, 2011
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Nov 2, 2017
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Dec 27, 2013
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Dec 9, 2012
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class II	Orthopedic	Contract manufacturing	Dec 9, 2024
MBX	Stimulator, Thalamic, Epilepsy, Implanted	Class III	Neurology	Contract manufacturing	Jun 8, 2021
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 2013
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Class III	Neurology	Contract manufacturing	Jun 8, 2021
MJW	Prosthesis, Subtalar, Plug, Polymer	Class II	Orthopedic	Contract manufacturing	Dec 27, 2013
MKY	System, Skin Closure	Class I	General and plastic surgery	Contract manufacturing	Dec 9, 2012
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Dec 8, 2012
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Sep 8, 2015
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Sep 6, 2011
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract manufacturing	Dec 27, 2013
MRU	Implanted Subcortical Electrical Stimulator (Motor Disorders)	HDE	Neurology	Contract manufacturing	Jun 8, 2021
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Dec 22, 2012
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence	Class II	Gastroenterology and urology	Contract manufacturing	Dec 10, 2015
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Oct 31, 2016
NDP	Accessories, Implant, Dental, Endosseous	Class I	Dental	Contract manufacturing	Nov 26, 2012
NEG	Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	Class III	Orthopedic	Contract manufacturing	Mar 26, 2014
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	Contract manufacturing	Oct 5, 2012
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Class III	Neurology	Contract manufacturing	Jun 8, 2021
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Sep 8, 2015
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Nov 6, 2018
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Dec 3, 2015
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Class II	Orthopedic	Contract manufacturing	Oct 31, 2017
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Dec 10, 2012
OIS	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Dec 9, 2024
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Dec 5, 2024
OJH	Orthopedic Tray	Class I	General and plastic surgery	Contract manufacturing	May 8, 2017
OJP	Orthopedic Computer Controlled Surgical System	Class II	Neurology	Contract manufacturing	Dec 8, 2012
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Dec 3, 2015
OMX	High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis	HDE	Orthopedic	Contract manufacturing	Mar 26, 2014
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 11, 2015
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract manufacturing	Nov 7, 2017
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Dec 3, 2015
OUG	Medical Device Data System	Class I	General hospital	Contract manufacturing	Dec 15, 2012
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Oct 23, 2012
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Dec 15, 2012
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Sep 8, 2015
OWB	Interventional Fluoroscopic X-Ray System	Class II	Radiology	Contract manufacturing	Nov 16, 2015
OWI	Bone Fixation Cerclage, Sublaminar	Class II	Orthopedic	Contract manufacturing	Dec 3, 2015
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Class II	Radiology	Contract manufacturing	Nov 16, 2015
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Class III	Neurology	Contract manufacturing	Jun 8, 2021
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class II	Orthopedic	Contract manufacturing	Dec 9, 2024
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Class II	Cardiovascular	Contract manufacturing	Nov 6, 2018
PLF	Bone Wedge	Class II	Orthopedic	Contract manufacturing	Nov 21, 2018
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	Orthopedic	Contract manufacturing	Jan 15, 2019
PST	Aortic Annuloplasty Ring	Class II	Cardiovascular	Contract manufacturing	Nov 22, 2017
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Class III	Gastroenterology and urology	Contract manufacturing	Dec 10, 2024
QSZ	Absorbable Synthetic Wound Dressing	Unclassified	General and plastic surgery	Contract manufacturing	Nov 29, 2018
QXV	Temperature Regulation Device For Esophageal Protection During Cardiac Ablation	Class II	Cardiovascular	Contract manufacturing	Jun 10, 2024

QUALITY TECH SERVICES, LLC

Devices listed as contract work

Other contract facilities of QUALITY TECH SERVICES, LLC