FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97609–97632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1996
GASTRIN EIA MODEL 06B-555017
K961276 · CGC
Biosyn , Ltd.
Chemistry · 57d
Cleared May 30, 1996
BEC SHROUDED PLASTIC CANNULA
K961328 · FMI
Biological & Environmental Control...
General Hospital · 52d
Cleared May 30, 1996
LIFE AND LIFE FAST SET
K961708 · EJK
Sybron Dental Specialties, Inc.
Dental · 28d
Cleared May 29, 1996
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559 · GGT
Nichols Institute
Hematology · 362d
Cleared May 29, 1996
ENERGIZED CONTAINER SYSTEM (MODIFICATION)
K954283 · FPA
Abbott Laboratories
General Hospital · 267d
Cleared May 29, 1996
SOLAR 9000 ANESTHESIA INFORMATION MONITOR
K954852 · DSI
Marquette Electronics, Inc.
Cardiovascular · 219d
Cleared May 29, 1996
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · LHI
Abbott Laboratories
General Hospital · 148d
Cleared May 29, 1996
ISG VIEWING WAND
K960714 · HAW
I.S.G. Technologies, Inc.
Neurology · 98d
Cleared May 29, 1996
VENTRAK RMMS 1550
K960831 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 90d
Cleared May 29, 1996
OCCLUSION BALLOON CATHETER
K960832 · MJN
Interventional Therapeutics Corp.
Cardiovascular · 90d
Cleared May 29, 1996
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · HPZ
Porex Technologies Corp. of Georgia
Ophthalmic · 89d
Cleared May 29, 1996
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
K960901 · LNH
Medrad, Inc.
Radiology · 85d
Cleared May 29, 1996
NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE
K960911 · LMD
Scimage, Inc.
Radiology · 84d
Cleared May 29, 1996
STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200
K960956 · EJT
Sterngold/Implamed
Dental · 79d
Cleared May 29, 1996
MOVABLE ADD-ON COUCH FOR OUTLOOK
K960973 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 79d
Cleared May 29, 1996
SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE)...
K961447 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 43d
Cleared May 29, 1996
PHONAK SONA P2
K961653 · ESD
Phonak, Inc.
Ear, Nose, Throat · 29d
Cleared May 29, 1996
ELECTRIC SEAT LIFT CHAIR
K961663 · INO
Ken Kemmerer
Physical Medicine · 56d
Cleared May 29, 1996
ARGOSY PROGRAMMABLE
K961729 · ESD
Argosy Electronics
Ear, Nose, Throat · 26d
Cleared May 29, 1996
ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
K961743 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 26d
Cleared May 28, 1996
PERRY SPECIALTIES DESIGNS NEEDLE GUARD
K932889 · FMI
Perry Specialties Design, Inc.
General Hospital · 1079d
Cleared May 28, 1996
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K945559 · FIP
Mar Cor Services, Inc.
Gastroenterology & Urology · 565d
Cleared May 28, 1996
JAZZY
K945936 · ITI
Pride Health Care, Inc.
Physical Medicine · 540d
Cleared May 28, 1996
SULLIVAN NOSE & MOUTH MASK SYSTEM
K952475 · BZD
Rescare , Ltd.
Anesthesiology · 364d