Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78001–78024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2001
ZIPPY, MODEL I88WA
K012846 · ITI
Pillar Technology, Inc.
Physical Medicine · 89d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872 · HWC
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 20, 2001
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM
K012875 · LNH
GE Medical Systems
Radiology · 85d
Cleared Nov 20, 2001
THE BIOPLATE MANDIBLE FIXATION SYSTEM
K012910 · JEY
Bioplate, Inc.
Dental · 82d
Cleared Nov 20, 2001
POWER DRIVE
K012944 · EKX
Mediteam AB
Dental · 77d
Cleared Nov 20, 2001
BIOSCANNER 2000
K013068 · CGA
Polymer Technology Systems, Inc.
Chemistry · 145d
Cleared Nov 20, 2001
MEDSTAR 150
K013081 · IPF
Mednet Services, Inc.
Physical Medicine · 67d
Cleared Nov 20, 2001
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K013220 · LPL
Poly Vue Technolgies, Inc.
Ophthalmic · 55d
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