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
146185–146208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · DRO
Life Science Instrumentation, Inc.
Cardiovascular · 250d
Cleared Nov 05, 1985
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE
K851153 · JPA
Astral Medical Systems
Hematology · 228d
Cleared Nov 05, 1985
FLEXISTAND MAJOR
K852152
Zygotek Assoc.
Physical Medicine · 172d
Cleared Nov 05, 1985
URI-CATH SYSTEM
K852490 · KNX
Gesco Intl., Inc.
Gastroenterology & Urology · 146d
Cleared Nov 05, 1985
7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS
K852791 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 127d
Cleared Nov 05, 1985
COMFORT + LIFT
K852812 · INO
Invacare Corp.
Physical Medicine · 126d
Cleared Nov 05, 1985
CR 280/45, CR281/4 DEFIBRILLATOR
K852905 · LDD
Cardiac Recorders, Ltd.
Cardiovascular · 119d
Cleared Nov 05, 1985
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
K852969 · LIQ
Cambridge Bioscience Corp.
Microbiology · 113d
Cleared Nov 05, 1985
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · GKL
Diagnostic Technology, Inc.
Hematology · 110d
Cleared Nov 05, 1985
SETMA VHT
K853163 · ILJ
Setma, Inc.
Physical Medicine · 98d
Cleared Nov 05, 1985
COMPAS 1
K853209 · DSI
Cardiac Care Units, Inc.
Cardiovascular · 97d
Cleared Nov 05, 1985
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
K853239 · KFF
Haemachem, Inc.
Hematology · 96d
Cleared Nov 05, 1985
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI
K853253 · KNT
Corpak Co.
Gastroenterology & Urology · 95d
Cleared Nov 05, 1985
MULTIPLE
K853297 · ISA
Sun Air, Inc.
Physical Medicine · 91d
Cleared Nov 05, 1985
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 89d
Cleared Nov 05, 1985
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 05, 1985
THE MOVER
K853424 · IOR
Invacare Corp.
Physical Medicine · 83d
Cleared Nov 05, 1985
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06
K853518 · DTB
Intermedics, Inc.
Cardiovascular · 75d
Cleared Nov 05, 1985
POWER DRIVE WHEELCHAIR
K853649 · ITI
Everest & Jennings, Inc.
Physical Medicine · 63d
Cleared Nov 05, 1985
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666 · FGE
E-Z-Em, Inc.
Gastroenterology & Urology · 63d
Cleared Nov 05, 1985
INFUSION CATHETER
K853997 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
GUIDE WIRE
K853999 · DQX
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
INFUSION CATHETER W/SIDE HOLES
K854000 · DQY
Target Therapeutics
Cardiovascular · 36d
Cleared Nov 05, 1985
RENALFO HEMOFILTER CAVHD
K854011 · KDI
Renal Systems, Inc.
Gastroenterology & Urology · 36d