FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92737–92760 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1997
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
K973063 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 8d
Cleared Aug 25, 1997
NITRILE GLOVES
K970135 · LZC
Sage Products, Inc.
General Hospital · 222d
Cleared Aug 25, 1997
SAFARI
K970646 · INI
Ranger All Season Corp.
Physical Medicine · 195d
Cleared Aug 25, 1997
ACCUTEMP-PROBE
K970686 · FMT
Kentec Medical, Inc.
General Hospital · 181d
Cleared Aug 25, 1997
GYREX PRIMA 1TG 1.0T MRI SYSTEM
K970990 · LNH
Elscint Mr, Inc.
Radiology · 160d
Cleared Aug 25, 1997
DASH, SULLIVAN, VITAL GARD
K971044 · LYY
Dash Medical Gloves, Inc.
General Hospital · 157d
Cleared Aug 25, 1997
LAPARETTE
K971146 · KNF
Rd Chus, Inc.
Obstetrics & Gynecology · 150d
Cleared Aug 25, 1997
VIEWCATH 3-D CATHETER PULLBACK
K971397 · ITX
Quinton, Inc.
Radiology · 132d
Cleared Aug 25, 1997
REPICCI II UNICONDYLAR KNEE
K971938 · HRY
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 25, 1997
NPB-190 PULSE OXIMETER (NPB-190)
K971946 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 90d
Cleared Aug 25, 1997
KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER
K971973 · LLZ
Eastman Kodak Company
Radiology · 88d
Cleared Aug 25, 1997
SLEEP-IN BONE SCREW SYSTEM
K972023 · LRK
Influence, Inc.
Dental · 84d
Cleared Aug 25, 1997
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
K972039 · ESD
Nu-Sound
Ear, Nose, Throat · 84d
Cleared Aug 25, 1997
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141 · KQO
Intl. Remote Imaging Systems
Chemistry · 80d
Cleared Aug 25, 1997
ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING
K972142 · DQX
Guidant Corp.
Cardiovascular · 80d
Cleared Aug 25, 1997
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-2)
K972147 · ITI
Dynamic Systems, Inc.
Physical Medicine · 77d
Cleared Aug 25, 1997
OSTEO ANATOMICAL BONE PLATES
K972196 · HRS
Osteonics Corp.
Orthopedic · 76d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP B
K972386 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP A
K972387 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP C
K972388 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H D
K972389 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H C
K972390 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H B
K972391 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · GNC
Lee Laboratories, Inc.
Microbiology · 60d