FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122185–122208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 1991
MODIFIED PK TP CONTROL
K911266 · GMT
Olympus Corp.
Microbiology · 53d
Cleared May 07, 1991
STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
K911579 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 35d
Cleared May 07, 1991
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · LKO
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNOWELL SM ANTIBODY TEST
K911851 · LKP
General Biometrics, Inc.
Immunology · 11d
Cleared May 06, 1991
GLOBALCARE MICRO 11 AND MICROCARE (TENS)
K903394 · GZJ
Globalcare Intl., Inc.
Neurology · 283d
Cleared May 06, 1991
OLYMPUS PK-TP ABSORBENT KIT
K905038 · GMT
Fujirebio America, Inc.
Microbiology · 181d
Cleared May 06, 1991
SPIROSCOPE
K905480 · BZC
Grandcor Medical Systems
Anesthesiology · 151d
Cleared May 06, 1991
FHT (FECAL HEME TEST)
K905782 · KHE
Aerscher, Inc.
Hematology · 136d
Cleared May 06, 1991
PTI STERNAL CLOSURE WIRE SUTURE
K910067 · GAQ
Pioneering Technologies, Inc.
General & Plastic Surgery · 117d
Cleared May 06, 1991
CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.
K910496 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1991
HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM
K910500 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared May 06, 1991
FREEDOM MARK III SURGICAL HELMET SYSTEM
K910515 · FYA
Stackhouse Assoc.
General Hospital · 90d
Cleared May 06, 1991
VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
K910564 · FOZ
Menlo Care, Inc.
General Hospital · 87d
Cleared May 06, 1991
TOUCHLESS II INTERMITTENT CATHETER
K910653 · FCM
C.R. Bard, Inc.
Gastroenterology & Urology · 81d
Cleared May 06, 1991
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721 · JIS
Biotrol, USA, Inc.
Chemistry · 75d
Cleared May 06, 1991
OPTHLAMIC FRAMES
K910951 · HQZ
United Optical, Spa
Ophthalmic · 62d
Cleared May 06, 1991
MULTIPLE, SURGICAL DRAPE PACK
K911132 · FZI
Central Georgia Ancillary Health Systems
General & Plastic Surgery · 53d
Cleared May 06, 1991
SPECTACLE FRAME
K911332 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 41d
Cleared May 06, 1991
CLEARBLUE EASY
K911566 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared May 03, 1991
VARIAN ELECTRONIC PORTAL IMAGING SYSTEM
K901932 · IYE
Varian Assoc., Inc.
Radiology · 368d
Cleared May 03, 1991
VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
K905235 · CBK
Percussionaire Corp.
Anesthesiology · 177d
Cleared May 03, 1991
OHMEDA MODULUS CD ANESTHESIA SYSTEM
K905635 · BSZ
Ohmeda Medical
Anesthesiology · 137d