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

Filters: Cleared only ×
175,820 results
118537–118560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1992
MODIFIED ASAHI PAN-SERIES HEMOFILTERS
K914020 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Mar 20, 1992
GLASS IONOMER CEMENT
K914318 · EMA
Confi-Dental Products Co.
Dental · 176d
Cleared Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · GBM
American Medical Systems, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 20, 1992
ENDOTRACHEAL CPAP SET
K915277 · BTR
Vital Signs, Inc.
Anesthesiology · 116d
Cleared Mar 20, 1992
OVER THE WIRE STONE BASKET
K915538 · LQR
Medical Dynamics, Inc.
Gastroenterology & Urology · 101d
Cleared Mar 20, 1992
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
K915804 · CCW
Propper Mfg. Co., Inc.
Anesthesiology · 87d
Cleared Mar 20, 1992
SIENET DIAGNOSTIC REPORTING CONSOLE
K920309 · LLZ
Siemens Gammasonics, Inc.
Radiology · 57d
Cleared Mar 20, 1992
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · KLE
3M Company
Dental · 46d
Cleared Mar 20, 1992
3M BRAND RESTORATIVE Z100
K920425 · EBF
3M Company
Dental · 46d
Cleared Mar 20, 1992
WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX
K920557 · EBI
Wilde-USA, Inc.
Dental · 44d
Cleared Mar 20, 1992
POLAR PAD (STERILE)
K920581 · ILO
Breg, Inc.
Physical Medicine · 39d
Cleared Mar 20, 1992
ORTHODONTIC FACE BOW W/ INNER WIRE
K920784 · DZB
Gac Intl., Inc.
Dental · 29d
Cleared Mar 20, 1992
MANUAL CHAIR BASE
K921027 · KNN
Labac Systems, Inc.
Physical Medicine · 17d
Cleared Mar 19, 1992
OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.
K910929 · DSI
Ohmeda Medical
Cardiovascular · 380d
Cleared Mar 19, 1992
HOMEVUE MONITORING SYS.MODEL TD 2000
K912138 · HGM
Homevue Health Systems, Inc.
Obstetrics & Gynecology · 310d
Cleared Mar 19, 1992
RG27-SERIES RESECTOSCOPE AND ACCESSORIES
K914108 · HIH
CooperSurgical, Inc.
Obstetrics & Gynecology · 188d
Cleared Mar 19, 1992
PALAVIT G
K914513 · EGD
Heraeus Kulzer, Inc.
Dental · 162d
Cleared Mar 19, 1992
SURGICAL CLOTH TAPE (HEALRITE)
K914596 · KGX
Industrias Tuk, S.A. DE C.V.
General & Plastic Surgery · 155d
Cleared Mar 19, 1992
SURGICAL MICROPOROUS TAPE (MICROCEL)
K914597 · KGX
Industrias Tuk, S.A. DE C.V.
General & Plastic Surgery · 155d
Cleared Mar 19, 1992
1-125 ENDOSEED
K914825 · KXK
Endo Technic Corp.
Radiology · 143d
Cleared Mar 19, 1992
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
K915053 · GTQ
Beckman Instruments, Inc.
Microbiology · 140d
Cleared Mar 19, 1992
CANN-HOLD
K915057 · KGX
O.R. Concepts, Inc.
General & Plastic Surgery · 132d
Cleared Mar 19, 1992
ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
K915099 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 128d
Cleared Mar 19, 1992
NEW OPAQUE PORCELAIN
K915543 · EIH
Dentsply Intl.
Dental · 100d