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

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175,820 results
121705–121728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1991
UNIPOLAR COAGULATOR PROBE SYSTEM
K911274 · GEI
American Surgical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Jun 20, 1991
OBTRASOUND STETHOSCOPE FETAL CALC
K911453 · KNG
Medasonics, Inc.
Radiology · 78d
Cleared Jun 20, 1991
FLEXIBLE CHOLEDOCHOSCOPE
K911480 · FBN
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 20, 1991
MEADOX(R) SURGIMED(R) BIOPSY GUN II
K911635 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 20, 1991
IMMULITE(TM) HCG
K911796 · DHA
Cirrus Diagnostics, Inc.
Chemistry · 59d
Cleared Jun 20, 1991
RX-5000 MRI SYSTEM
K911892 · LNH
Resonex, Inc.
Radiology · 55d
Cleared Jun 20, 1991
TELEX MODEL TLP, IN-THE-EAR
K912204 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Jun 20, 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · JLW
Baxter Healthcare Corp
Chemistry · 30d
Cleared Jun 20, 1991
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
K912324 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Jun 20, 1991
BIPROBE(TM)
K912601 · KNS
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Jun 19, 1991
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · DTC
Bio-Tek Instruments, Inc.
Cardiovascular · 295d
Cleared Jun 19, 1991
MGA-IR SIDESTREAM PCO2 MODULE
K904863 · CCK
Marquette Gas Analysis Corp.
Anesthesiology · 233d
Cleared Jun 19, 1991
GASTROSCAN
K905154 · FFX
Medics Instrument Corp.
Gastroenterology & Urology · 216d
Cleared Jun 19, 1991
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K905313 · DSP
Kontron Instruments, Inc.
Cardiovascular · 203d
Cleared Jun 19, 1991
INTRAN PLUS
K905563 · KXO
Utah Medical Products, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 19, 1991
XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
K905573 · BSS
Zeon Medical Corp.
Gastroenterology & Urology · 189d
Cleared Jun 19, 1991
PORTABLE AUTO TRANSFUSION SYSTEM 500
K910238 · CAC
Electromedics, Inc.
Anesthesiology · 152d
Cleared Jun 19, 1991
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 148d
Cleared Jun 19, 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · JWH
Osteonics Corp.
Orthopedic · 104d
Cleared Jun 19, 1991
CHOLANGIOCATH AND ATRAUMATIC BOWEL CLAMP
K911243 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jun 19, 1991
VARIOUS X-RAY TUBES
K911695 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 64d
Cleared Jun 19, 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469 · BTO
Bivona Medical Technologies
Anesthesiology · 15d
Cleared Jun 18, 1991
VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM
K904328 · GWK
Telediagnostic Systems, Inc.
Neurology · 271d
Cleared Jun 18, 1991
CENTAURI YAG LASER SYST, NEUROSURGERY
K904631 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 252d