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
74305–74328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2002
M2 SINGLE USE MICROKERTOME
K022560 · HMY
Moria SA
Ophthalmic · 56d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851 · JJY
Quidel Corp.
Chemistry · 31d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901 · JIS
Ortho-Clinical Diagnostics
Chemistry · 24d
Cleared Sep 26, 2002
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
K020457 · HRX
Axiamed, Inc.
Orthopedic · 227d
Cleared Sep 26, 2002
DOCXS B SERIES ELECTRODES
K020903 · GXY
Docxs, LLC
Neurology · 190d
Cleared Sep 26, 2002
CHLORAPREP
K021131 · LBH
Centrix, Inc.
Dental · 171d
Cleared Sep 26, 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · DQA
Welch Allyn, Inc.
Anesthesiology · 91d
Cleared Sep 26, 2002
AUTO*THERM 395, MODEL ME 395
K022458 · IMJ
Mettler Electronics Corp.
Physical Medicine · 62d
Cleared Sep 26, 2002
PULPDENT PUTTY DAM
K022522 · EIE
Pulpdent Corporation
Dental · 58d
Cleared Sep 26, 2002
CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE...
K022792 · LYY
Seal Polymer Industries Bhd.
General Hospital · 35d
Cleared Sep 26, 2002
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA...
K023020 · IXA
Agfa Corp.
Radiology · 15d
Cleared Sep 26, 2002
TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
K023024 · ITX
Vascular Control Systems, Inc.
Radiology · 15d
Cleared Sep 26, 2002
MICRORUPTER V
K023045 · LXS
Meridian AG
Ophthalmic · 14d
Cleared Sep 26, 2002
REPLACE TIUNITE ENDOSSEOUS IMPLANT
K023113 · DZE
Nobel Biocare Uas, Inc.
Dental · 7d
Cleared Sep 25, 2002
INJEX NEEDLE-FREE INJECTION SYSTEM
K020786 · KZE
Rosch AG Medizintechnic
General Hospital · 198d
Cleared Sep 25, 2002
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER)
K020879 · FZP
Integrated Vascular Systems, Inc.
General & Plastic Surgery · 191d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 98d
Cleared Sep 25, 2002
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 &...
K022100 · HAW
Image-Guided Neurologics, Inc.
Neurology · 89d
Cleared Sep 25, 2002
ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES...
K022659 · LYY
Purna Bina Sdn Bhd
General Hospital · 47d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 47d
Cleared Sep 25, 2002
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL &...
K022889 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 26d
Cleared Sep 25, 2002
BARDPORT X-PORT ISP PORT
K022983 · LJT
C.R. Bard, Inc.
General Hospital · 16d