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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69673–69696 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 20, 2003
ARAMIS II DERMATOLOGICAL LASER
K032260 · GEX
Quantel Medical
General & Plastic Surgery · 121d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · MQV
Biomet Orthopedics, Inc.
Orthopedic · 119d
Cleared Nov 20, 2003
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT...
K032331 · HBL
Pro-Med Instruments GmbH
Neurology · 114d
Cleared Nov 20, 2003
QUASAR, MODEL MD21
K032379 · ILY
Quantum Skincare, Inc.
Physical Medicine · 111d
Cleared Nov 20, 2003
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
K032613 · LDF
Peter M. Rothenberg, M.D.
Cardiovascular · 87d
Cleared Nov 20, 2003
PLASTALGIN AND PLASTALGIN ORTHO
K032708 · ELW
Septodont
Dental · 79d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739 · MNI
Seaspine
Orthopedic · 77d
Cleared Nov 20, 2003
NEUROLASE, MODELS 150V, 150C, 1064
K032787 · ILY
Spectrum Laser & Technologies
Physical Medicine · 73d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · MBF
Biomet, Inc.
Orthopedic · 64d