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
77401–77424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2001
CYBERCASES BY BAUSCH & LOMB
K013232 · LRX
Bausch & Lomb, Inc.
Ophthalmic · 54d
Cleared Nov 20, 2001
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
K013239 · FMQ
Med Gen, Inc.
General Hospital · 53d
Cleared Nov 20, 2001
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
K013265 · JJY
Maine Standards Co.
Chemistry · 50d
Cleared Nov 20, 2001
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
K013332 · JJY
Cliniqa Corporation
Immunology · 42d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 40d
Cleared Nov 20, 2001
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS...
K013467 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 33d
Cleared Nov 20, 2001
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K013469 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 33d
Cleared Nov 20, 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · MOS
Mri Devices Corp.
Radiology · 29d
Cleared Nov 20, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K013540 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 27d
Cleared Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS),...
K013566 · CEW
Diagnostic Products Corp.
Chemistry · 25d
Cleared Nov 20, 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · MOS
Mri Devices Corp.
Radiology · 20d
Cleared Nov 20, 2001
EFILM VIDEO
K013631 · LMA
Efilm Medical, Inc.
Radiology · 15d
Cleared Nov 20, 2001
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K013782 · FMI
Disetronic Medical Systems
General Hospital · 6d
Cleared Nov 19, 2001
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
K011322 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 202d
Cleared Nov 19, 2001
STARS2000 POWER CANNULA
K012236 · QPB
Kmi Kolster Methods, Inc.
General & Plastic Surgery · 125d
Cleared Nov 19, 2001
CYNOSURE PHOTOGENICA VL
K012806 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Nov 19, 2001
RECORDING AND STIMULATING ELECTRODE
K012850 · GZL
Radionics, A Division of Tyco...
Neurology · 87d
Cleared Nov 19, 2001
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · HJO
Bausch & Lomb, Inc.
Ophthalmic · 84d
Cleared Nov 19, 2001
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735
K012929 · FAJ
Circon Video
Gastroenterology & Urology · 80d
Cleared Nov 19, 2001
SCREW VENT IMPLANT
K013227 · DZE
Sulzer Dental, Inc.
Dental · 53d
Cleared Nov 19, 2001
SF SH CATHETER, MODEL R65-945
K013437 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 33d
Cleared Nov 19, 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · LKF
A & A Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · FGE
Cook, Inc.
Gastroenterology & Urology · 261d