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
73801–73824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
CARDIS
K023015 · DQK
Schwarzer GmbH
Cardiovascular · 15d
Cleared Sep 24, 2002
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280 · BZG
Morgan Medical , Ltd.
Anesthesiology · 239d
Cleared Sep 24, 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K020712 · GZJ
Biomedical Life Systems, Inc.
Neurology · 203d
Cleared Sep 24, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES
K021152 · NAY
Computer Motion, Inc.
General & Plastic Surgery · 167d
Cleared Sep 24, 2002
ICASE
K021248 · LRX
Ikeeps, Inc.
Ophthalmic · 158d
Cleared Sep 24, 2002
FIRST CHOICE & FIRST CHOICE PLUS
K022076 · GZJ
Body Clock Health Care, Ltd.
Neurology · 90d
Cleared Sep 24, 2002
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · KWT
Biomet, Inc.
Orthopedic · 90d