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
70177–70200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · MHX
Ge Medical Systems Information...
Cardiovascular · 20d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · KHE
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 12d
Cleared Nov 21, 2003
CONTEC DUO, CONTEC LC, CONTEC LCR
K030644 · DYH
Dentaurum
Dental · 266d
Cleared Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K031842 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 158d
Cleared Nov 21, 2003
ELECTRO FLO PERCUSSOR, MODEL 5000
K031876 · BYI
Med Systems
Anesthesiology · 157d
Cleared Nov 21, 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · JIX
Olympus America, Inc.
Chemistry · 85d
Cleared Nov 21, 2003
AERONEB GO NEBULIZER, MODEL AG-AG2000
K032849 · CAF
Aerogen, Inc.
Anesthesiology · 70d
Cleared Nov 21, 2003
UNIMARK HOME PREGNANCY TEST DEVICE
K032992 · LCX
Biotech Atlantic, Inc.
Chemistry · 57d
Cleared Nov 21, 2003
PROTEMP 3 GARANT
K033022 · EBG
3M Espe AG Dental Products
Dental · 57d
Cleared Nov 21, 2003
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
K033041 · LCX
ACON Laboratories, Inc.
Chemistry · 53d
Cleared Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314 · FGE
Ev3, Inc.
Gastroenterology & Urology · 37d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Nov 21, 2003
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE...
K033444 · MHX
Philips Medical Systems
Cardiovascular · 23d
Cleared Nov 21, 2003
LMT NOMAG IC 1,5
K033565 · FPL
Lmt Lammers Medical Technology GmbH
General Hospital · 9d
Cleared Nov 20, 2003
PLV CONTINUUM VENTILATOR, MODEL P1000
K022750 · NOU
Respironics California, Inc.
Anesthesiology · 458d
Cleared Nov 20, 2003
OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E
K023452 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 401d
Cleared Nov 20, 2003
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING...
K023537 · LYY
Sgmp Co., Ltd.
General Hospital · 395d
Cleared Nov 20, 2003
SYSTEM 100 ULTRAFILTRATION CATHETER
K023874 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 364d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · MNI
Ortho Tec, LLC
Orthopedic · 238d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978 · JWH
Howmedica Osteonics Corp.
Orthopedic · 237d
Cleared Nov 20, 2003
BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580
K031375 · IPF
Besmed Health Business Corp
Physical Medicine · 204d
Cleared Nov 20, 2003
GROWTH GUIDANCE PLATE
K031493 · HRS
University of Utah/School of Medicine
Orthopedic · 192d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
K031676 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 174d