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
75961–75984 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2002
UTERINE INJECTOR
K020292 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 79d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d
Cleared Apr 17, 2002
MYALLERGYTEST SYSTEM
K020387 · DHB
Immunetech Corporation
Immunology · 71d
Cleared Apr 17, 2002
PULPDENT GLAZE
K020432 · EBF
Pulpdent Corporation
Dental · 68d
Cleared Apr 17, 2002
PULPDENT POST CEMENT
K020481 · EMA
Pulpdent Corporation
Dental · 63d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE...
K020506 · LON
Dade Microscan, Inc.
Microbiology · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
bioMerieux, Inc.
Microbiology · 35d
Cleared Apr 17, 2002
NXSTAGE THERAPY SYSTEM
K020858 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890 · DQO
St Jude Medical
Cardiovascular · 29d
Cleared Apr 17, 2002
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X
K020940 · GAW
Sutura, Inc.
General & Plastic Surgery · 26d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · FRN
Smith & Nephew, Inc.
General Hospital · 23d
Cleared Apr 17, 2002
NICOLET ELECTROCAUTERY DETECTOR
K020955 · ETN
Nicolet Biomedical, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 17, 2002
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K021049 · OWB
Ge Oec Medical Systems
Radiology · 16d
Cleared Apr 17, 2002
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
K021077 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · FOZ
Micro Therapeutics, Inc.
General Hospital · 8d
Cleared Apr 16, 2002
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
K013300 · GEX
Technology Delivery Systems, Inc.
General & Plastic Surgery · 195d
Cleared Apr 16, 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
K013621 · FPA
Becton Dickinson Infusion Therapy...
General Hospital · 162d
Cleared Apr 16, 2002
ACTICHROME HEPARIN (ANTI-FIIA)
K013637 · KFF
American Diagnostica, Inc.
Hematology · 162d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · MQP
Synthes (Usa)
Orthopedic · 89d
Cleared Apr 16, 2002
CHIN ELECTRODE
K020468 · GXY
Dymedix, Inc.
Neurology · 63d
Cleared Apr 16, 2002
INTRASTENT LD (LARGE DIAMETER) STENT
K020528 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · KLS
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 22d