HARWOOD DESIGN, INC.

Contract manufacturer · Bristol, PA

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

2013Product codes first listed, by year (tallest: 30)2026

FDA registration: 3003761012 (openFDA record; or search FDA's registration database)
FEI number: 3003761012
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Harwood Design, Inc. (FDA owner/operator no. 10043110)
Registered address: 1507 Clyde Waite Drive, Bristol, PA 19007
Contract listings: 120 device listings, 74 product codes, first listed Jan 25, 2013
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
CCW	Laryngoscope, Rigid	Class I	Anesthesiology	Contract manufacturing	Jan 30, 2013
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Aug 3, 2016
DWS	Instruments, Surgical, Cardiovascular	Class I	Cardiovascular	Contract manufacturing	Jan 25, 2013
DXC	Clamp, Vascular	Class II	Cardiovascular	Contract manufacturing	Jan 25, 2013
EOQ	Bronchoscope (Flexible Or Rigid)	Class II	Ear, nose and throat	Contract manufacturing	Jun 21, 2016
EOX	Esophagoscope (Flexible Or Rigid)	Class II	Ear, nose and throat	Contract manufacturing	Jun 21, 2016
EPY	Speculum, Ent	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
EQH	Source, Carrier, Fiberoptic Light	Class I	Ear, nose and throat	Contract manufacturing	Jan 30, 2013
EQN	Laryngoscope, Nasopharyngoscope	Class II	Ear, nose and throat	Contract manufacturing	Jun 21, 2016
EWY	Mediastinoscope, Surgical	Class II	Ear, nose and throat	Contract manufacturing	Jun 21, 2016
FDG	Retractor, Fiberoptic	Class I	Gastroenterology and urology	Contract manufacturing	Jan 30, 2013
FFO	Retractor, Self-Retaining	Class I	Gastroenterology and urology	Contract manufacturing	Aug 3, 2016
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
FTY	Tape, Measuring, Rulers And Calipers	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jan 29, 2013
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
GDL	Needle, Suturing, Reusable	Class I	General and plastic surgery	Contract manufacturing	Jan 29, 2013
GDM	Needle, Aspiration And Injection, Reusable	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Apr 8, 2025
HCF	Instrument, Ligature Passing And Knot Tying	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Apr 8, 2025
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Aug 3, 2016
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
JDO	Device, Fixation, Proximal Femoral, Implant	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
JEK	Forceps, Biopsy, Bronchoscope (Rigid)	Class II	Ear, nose and throat	Contract manufacturing	Jun 21, 2016
JOH	Tube Tracheostomy And Tube Cuff	Class II	Anesthesiology	Contract manufacturing	Jun 21, 2016
JOL	Catheter And Tip, Suction	Class II	General hospital	Contract manufacturing	Aug 3, 2016
JZF	Tube, Ear Suction	Class I	Ear, nose and throat	Contract manufacturing	Aug 3, 2016
KAC	Tube, Laryngectomy	Class I	Ear, nose and throat	Contract manufacturing	Jan 30, 2013
KAK	Probe, Ent	Class I	Ear, nose and throat	Contract manufacturing	Aug 3, 2016
KCB	Tube, Tonsil Suction	Class I	Ear, nose and throat	Contract manufacturing	Jan 30, 2013
KCD	Bougie, Esophageal, Ent	Class I	Ear, nose and throat	Contract manufacturing	Jan 30, 2013
KGS	Retention Device, Suture	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
LLO	Laser, Neodymium:Yag, Pulmonary Surgery	Class II	Ear, nose and throat	Contract manufacturing	Aug 31, 2021
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
LRC	Instrument, Ent Manual Surgical	Class I	Ear, nose and throat	Contract manufacturing	Jan 30, 2013
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	Jan 29, 2013
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Dec 13, 2016
NQP	Posterior Metal/Polymer Spinal System, Fusion	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
NQW	Orthosis, Spine, Plate, Laminoplasty, Metal	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Dec 13, 2016
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
OQH	Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 29, 2013
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Mar 17, 2016
OWI	Bone Fixation Cerclage, Sublaminar	Class II	Orthopedic	Contract manufacturing	Apr 8, 2025
PGM	Growing Rod System	Class II	Orthopedic	Contract manufacturing	Apr 8, 2025
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Class II	Orthopedic	Contract manufacturing	Mar 13, 2026
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	Orthopedic	Contract manufacturing	Mar 13, 2026
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Mar 16, 2026