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
76873–76896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2001
SEREINE EXTRA STRENGTH DAILY CLEANER
K011561 · LPN
Wilsa, Inc.
Ophthalmic · 183d
Cleared Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · CFR
Bayer Corp.
Chemistry · 151d
Cleared Nov 20, 2001
'RAPIDONE'-METHADONE TEST
K012164 · DJR
American Bio Medica Corp.
Toxicology · 132d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K012818 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
LERMAN & SON CRANIAL ORTHOSIS HELMET
K012830 · MVA
Lerman & Son
Neurology · 89d
Cleared Nov 20, 2001
DUO PAL 6, ORDER-NO.: 2154
K012841 · EJS
Wieland Edelmetalle GmbH & Co.
Dental · 89d
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