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
120817–120840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1991
CARDIOCAP CMX-104 MONITOR
K903237 · DXN
Datex Division Instrumentarium Corp.
Cardiovascular · 359d
Cleared Jul 17, 1991
DERMALIGHT PSORACOMB
K903660 · IOB
Solitec GmbH
Physical Medicine · 341d
Cleared Jul 17, 1991
TOWNLEY TOTAL KNEE (TTK)
K904448 · JWH
Biopro, Inc.
Orthopedic · 292d
Cleared Jul 17, 1991
VITALMAX 2100/2200
K905274 · DRT
Pace Tech, Inc.
Cardiovascular · 244d
Cleared Jul 17, 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · LDD
Physio-Control Corp.
Cardiovascular · 184d
Cleared Jul 17, 1991
Q-SMART HOLTER SYSTEMS
K910808 · DSI
Quinton, Inc.
Cardiovascular · 141d
Cleared Jul 17, 1991
NUTIP (TM) SYRINGE SHIELD
K911214 · EKJ
Western M/D, Inc.
Dental · 120d
Cleared Jul 17, 1991
HEPCON HMS WITH BODY SURFACE AREA CALCULATION
K911240 · JOX
Hemotech, Inc.
Hematology · 118d
Cleared Jul 17, 1991
OLYMPUS AF ANGIOSCOPE SYSTEM
K911278 · LYK
Olympus Corp.
Cardiovascular · 114d
Cleared Jul 17, 1991
VZV IGM TEST
K911301 · GQX
Gull Laboratories, Inc.
Microbiology · 114d
Cleared Jul 17, 1991
GUM MASSAGER
K911418 · JET
Burn-Henderson Partnership
Dental · 107d
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