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
91273–91296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1997
INTERAX TOTAL KNEE SYSTEM
K973121 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 18, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K973128 · FOG
Olympus America, Inc.
Anesthesiology · 89d
Cleared Nov 18, 1997
IMTEC BONE TAC
K973180 · DZL
Imtec Corp.
Dental · 85d
Cleared Nov 18, 1997
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
K973293 · MPA
Vaughan Weeks
Ophthalmic · 77d
Cleared Nov 18, 1997
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
K973401 · DQO
Cordis Corp.
Cardiovascular · 70d
Cleared Nov 18, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656 · EMX
Specialty Surgical Products, Inc.
Ear, Nose, Throat · 54d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 35d
Cleared Nov 18, 1997
SUNGLASSES
K973934 · HQY
Elegance Optical Manufactory, Ltd.
Ophthalmic · 34d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
K973998 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 28d
Cleared Nov 17, 1997
HYDROTEC LOW AIR LOSS THERAPY BED
K970363 · IOQ
Apex Metal, Inc.
Physical Medicine · 290d
Cleared Nov 17, 1997
AIRTEC2 LOW AIR LOSS THERAPY BED
K970364 · IOQ
Apex Metal, Inc.
Physical Medicine · 290d
Cleared Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST...
K970505 · JOZ
Dade Intl., Inc.
Hematology · 280d
Cleared Nov 17, 1997
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES...
K970938 · DQX
Biocompatibles Cardiovascular, Inc.
Cardiovascular · 249d
Cleared Nov 17, 1997
VITAL-PORT INFUSION PAL
K971140 · LJT
Med Institute, Inc.
General Hospital · 234d
Cleared Nov 17, 1997
CHAD TOTAL O2 DELIVERY SYSTEM
K971889 · CAW
Chad Therapeutics, Inc.
Anesthesiology · 180d
Cleared Nov 17, 1997
POSITIVE PRESSURE CONNECTOR
K973167 · FPA
Icu Medical, Inc.
General Hospital · 84d
Cleared Nov 17, 1997
VERSAETCH
K973257 · EBF
Centrix, Inc.
Dental · 80d
Cleared Nov 17, 1997
KETAC-FIL APLICAP PLUS
K973262 · EMA
Espe GmbH & Co. Kg.
Dental · 80d
Cleared Nov 17, 1997
CAROLINE GUIDE/DELIA LOCALIZER
K973277 · HAW
Surgical Solutions, Inc.
Neurology · 76d
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305 · MDB
Organon Teknika Corp.
Microbiology · 75d
Cleared Nov 14, 1997
BONE-LOCK
K954030 · DZE
Leibinger GmbH
Dental · 809d
Cleared Nov 14, 1997
IBC CARDIAC SUCTION WARD
K963756 · DTS
International Biophysics Corp.
Cardiovascular · 423d
Cleared Nov 14, 1997
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · CBK
Puritan Bennett Corp.
Anesthesiology · 367d
Cleared Nov 14, 1997
RESTORE (A.K.A. CAPSURE)
K971359 · MNG
Nebl, Inc.
Gastroenterology & Urology · 217d