ZIEN MEDICAL TECHNOLOGIES LLC

Contract manufacturer · Salt Lake City, UT

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

2018Product codes first listed, by year (tallest: 14)2026

FDA registration: 3009756153 (openFDA record; or search FDA's registration database)
FEI number: 3009756153
Registered for: FDA registration year 2026
Establishment types: Specification developer; Manufacturer; Contract manufacturer
Owner or operator: Zien Medical Technologies LLC (FDA owner/operator no. 10047676)
Registered address: 2490 South 300 West, Salt Lake City, UT 84115
Contract listings: 23 device listings, 29 product codes, first listed Nov 16, 2018
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
BYX	Tubing, Pressure And Accessories	Class I	Anesthesiology	Contract manufacturing	Aug 23, 2021
EMH	Forceps, Rongeur, Surgical	Class I	Dental	Contract manufacturing	Aug 23, 2021
EMI	File, Bone, Surgical	Class I	Dental	Contract manufacturing	Aug 23, 2021
FLL	Continuous Measurement Thermometer	Class II	General hospital	Contract manufacturing	Mar 1, 2022
FMI	Needle, Hypodermic, Single Lumen	Class II	General hospital	Contract manufacturing	Feb 27, 2020
GAA	Needle, Aspiration And Injection, Disposable	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2021
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract manufacturing	Mar 24, 2026
GCQ	Endoscope, Flexible	Class II	Gastroenterology and urology	Contract manufacturing	Mar 24, 2026
HET	Laparoscope, Gynecologic (And Accessories)	Class II	Obstetrics and gynecology	Contract manufacturing	Mar 24, 2026
HRR	Scissors, Orthopedic, Surgical	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
HRX	Arthroscope	Class II	Orthopedic	Contract manufacturing	Aug 23, 2021
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2021
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Nov 19, 2025
HTP	File	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
HTS	Knife, Orthopedic	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
HTX	Rongeur	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 19, 2025
HWT	Template	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
IKD	Cable, Electrode	Class II	Physical medicine	Contract manufacturing	Mar 1, 2022
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	Contract manufacturing	Nov 16, 2018
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class II	Radiology	Contract manufacturing	Nov 16, 2018
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	May 12, 2022
KMK	Device, Intravascular Catheter Securement	Class I	General hospital	Contract manufacturing	May 1, 2020
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	Nov 16, 2018
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2021
MCW	Catheter, Peripheral, Atherectomy	Class II	Cardiovascular	Contract manufacturing	Oct 20, 2022
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Aug 23, 2021
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract manufacturing	May 5, 2020