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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121537–121560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1991
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
K910671 · FGE
Solos Endoscopy, Inc.
Gastroenterology & Urology · 84d
Cleared May 10, 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 70d
Cleared May 09, 1991
GRAVITY PLUS CONTROLLER/COMPOUNDER
K902853 · LHI
Fergy Corp.
General Hospital · 314d
Cleared May 09, 1991
RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
K904237 · FPP
Innovative Medical Technologies, Inc.
General Hospital · 234d
Cleared May 09, 1991
MODEL SW-103 SOLITANS STIMULATOR
K904264 · GZJ
Medical Consultants Intl. , Ltd.
Neurology · 233d
Cleared May 09, 1991
TROCAR ACCESS SHEATH
K905471 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 154d
Cleared May 09, 1991
LASER-35
K910200 · GEX
Endo Technic Corp.
General & Plastic Surgery · 114d
Cleared May 09, 1991
GLOVE-N-GEL AMNIOTOMY KIT
K910518 · HGE
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 92d
Cleared May 09, 1991
EDWARDS-WALLACE BOURNE HALL CATHETER
K910577 · MFD
Marlo Surgical Technology
Obstetrics & Gynecology · 87d
Cleared May 09, 1991
BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR
K910663 · GEI
Mdt Corp., Inc.
General & Plastic Surgery · 84d
Cleared May 09, 1991
CMI TENDER TOUCH VE #303TT AND 404TT
K910788 · HIS
Challenge Mfg., Inc.
Obstetrics & Gynecology · 73d
Cleared May 09, 1991
POWER SCAN 1000
K910802 · LNH
Webb Research, Inc.
Radiology · 72d
Cleared May 09, 1991
LIFELINER SURGICAL GLOVE
K910941 · FYE
Depuy-Raynham
General & Plastic Surgery · 64d
Cleared May 09, 1991
NHS 2009SP HEARING AID
K911174 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 09, 1991
NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
K911182 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d
Cleared May 09, 1991
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
K911275 · KPS
Positron
Radiology · 48d
Cleared May 09, 1991
CT SYTEC 4000
K911387 · JAK
GE Medical Systems
Radiology · 41d
Cleared May 09, 1991
PERRY(R) ENCORE CHEMOTHERAPY GLOVE
K911633 · LYY
Smith & Nephew Perry
General Hospital · 28d
Cleared May 09, 1991
RAICHEM SPIA C4 REAGENT
K911899 · DBI
Reagents Applications, Inc.
Immunology · 13d
Cleared May 09, 1991
RAICHEM SPIA C3 REAGENT
K911900 · CZW
Reagents Applications, Inc.
Immunology · 13d
Cleared May 08, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
K905571 · LIH
Biomedical Life Systems, Inc.
Neurology · 147d
Cleared May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared May 08, 1991
ROCHE APOLIPOPROTEIN STANDARD
K910553 · DER
Roche Diagnostic Systems, Inc.
Immunology · 90d
Cleared May 08, 1991
TRO-GARD
K910678 · KGX
Conmedcorp
General & Plastic Surgery · 82d