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
120553–120576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1991
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 105d
Cleared Jul 17, 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
K911500 · JAK
Shimadzu Medical Systems
Radiology · 105d
Cleared Jul 17, 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
K911501 · JAK
Shimadzu Medical Systems
Radiology · 105d
Cleared Jul 17, 1991
VISION BG TEST STRIP
K911624 · CGA
British-American Medical, Inc.
Chemistry · 97d
Cleared Jul 17, 1991
AIRSTRIP FIRST AID & POST-OP DRESSING
K911682 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 93d
Cleared Jul 17, 1991
SCISSORS,GRASPERS,FORCEPS
K911754 · GCJ
American Cynamid Co.
General & Plastic Surgery · 90d
Cleared Jul 17, 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · CIG
Trace Scientific , Ltd.
Chemistry · 82d
Cleared Jul 17, 1991
CODMAN PEDIATRIC HORSESHOE HEADREST
K911917 · HBM
Codman & Shurtleff, Inc.
Neurology · 78d
Cleared Jul 17, 1991
SWIVEL HORSESHOE HEADREST
K911918 · HBM
Codman & Shurtleff, Inc.
Neurology · 78d
Cleared Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
K911994 · GFO
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · GJS
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
K911996 · JCA
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
TENDERFOOT(R), MODIFICATION
K911997 · FMK
International Technidyne Corp.
Hematology · 86d
Cleared Jul 17, 1991
PX COULTER(R) CELL CONTROL
K912133 · JPK
Coulter Electronics, Inc.
Hematology · 64d
Cleared Jul 17, 1991
XY IMAGING TABLE
K912135 · IYZ
Med-Tron Products, Inc.
Radiology · 64d
Cleared Jul 17, 1991
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150 · GTQ
Beckman Instruments, Inc.
Microbiology · 63d
Cleared Jul 17, 1991
E-Z LIFT CRANK IMAGING TABLE
K912181 · IYZ
Med-Tron Products, Inc.
Radiology · 62d
Cleared Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
K912386 · CEF
Helena Laboratories
Chemistry · 82d
Cleared Jul 17, 1991
MODELS 5,8,20,20S ARGON ION LASERS
K912438 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 44d
Cleared Jul 17, 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · CGA
Home Diagnostics, Inc.
Chemistry · 44d
Cleared Jul 17, 1991
LINEARITY TEST KITS
K912441 · JJY
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Jul 17, 1991
NOVA 12 ANALYZER
K912560 · JGS
Nova Biomedical Corp.
Chemistry · 36d
Cleared Jul 17, 1991
SYNERMED PHOSPHORUS REAGENT KIT
K912569 · CEO
Synermed, Inc.
Chemistry · 36d
Cleared Jul 17, 1991
ISE/CI-
K912647 · CGZ
Boehringer Mannheim Corp.
Chemistry · 30d