FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75217–75240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · NBC
Biosite Incorporated
Chemistry · 67d
Cleared Jul 01, 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Jul 01, 2002
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
K021825 · KWP
Unitedstates Surgical
Orthopedic · 27d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828 · HWC
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2002
OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS...
K021831 · LZU
Lacrimedics, Inc.
Ophthalmic · 27d
Cleared Jul 01, 2002
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
K021869 · GXD
Diros Technology, Inc.
Neurology · 25d
Cleared Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
K021883 · HWC
Mitek Worldwide
Orthopedic · 24d
Cleared Jul 01, 2002
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · GWJ
Bio-Logic Systems Corp.
Neurology · 21d
Cleared Jun 28, 2002
SNORE SAT RECORDER, MODEL SS41
K002159 · MNR
Sagatech Electronics, Inc.
Anesthesiology · 711d
Cleared Jun 28, 2002
BODY FORCE, MODEL BT 6000
K020211 · JOW
Composites Solutions, Inc.
Cardiovascular · 157d
Cleared Jun 28, 2002
BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
K020382 · DRX
Medicotest A/S
Cardiovascular · 143d
Cleared Jun 28, 2002
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K020932 · CAF
Sunrise Medical
Anesthesiology · 98d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 85d
Cleared Jun 28, 2002
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
K021140 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 28, 2002
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021229 · DDR
Beckman Coulter, Inc.
Chemistry · 71d
Cleared Jun 28, 2002
VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE...
K021290 · GCJ
Vista Medical Technologies, Inc.
General & Plastic Surgery · 66d
Cleared Jun 28, 2002
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL...
K021305 · DXN
Microlife Corp.
Cardiovascular · 65d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM...
K021345 · FGE
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Jun 28, 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · IPF
Apex Medical Corp.
Physical Medicine · 30d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · CGA
Lifescan, Inc.
Chemistry · 31d
Cleared Jun 27, 2002
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
K003720 · KPL
Lifestream Purfication Systems, LLC
Gastroenterology & Urology · 570d
Cleared Jun 27, 2002
REPROCESSED ELECTROSURGICAL ELECTRODES
K012669 · GEI
Surgical Instruments Service and...
General & Plastic Surgery · 318d
Cleared Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · LZU
Oasis Medical, Inc.
Ophthalmic · 234d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · GKP
Dade Behring, Inc.
Hematology · 93d