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
80017–80040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 8d
Cleared Feb 28, 2001
MAC ACUPUNCTURE NEEDLE
K002827 · MQX
Haenglim Seowon Corp.
General Hospital · 170d
Cleared Feb 28, 2001
VASCULAR ARCHITECTS PERISCOPE DEVICE
K003719 · DWX
Vascular Architects, Inc.
Cardiovascular · 86d
Cleared Feb 28, 2001
ALI 3D TOOL MODULE FOR MEDICAL IMAGES
K003762 · LLZ
A.L.I. Technologies, Inc.
Radiology · 84d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 82d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865 · DKZ
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Feb 28, 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · LTJ
Dade Behring, Inc.
Immunology · 68d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 28, 2001
FLUOROPERM 151-OK, PARAGON HDS 100-OK
K010109 · MUW
Paragon Vision Sciences
Ophthalmic · 47d
Cleared Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
K010111 · JJY
Medical Analysis Systems, Inc.
Chemistry · 47d
Cleared Feb 28, 2001
TETRIC CERAM HB
K010250 · EBF
Ivoclar North America, Inc.
Dental · 33d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257 · MKJ
Zoll Medical Corp
Cardiovascular · 30d
Cleared Feb 28, 2001
CARDIOMEDICS ECP SYSTEM
K010261 · DRN
Cardiomedics, Inc.
Cardiovascular · 30d
Cleared Feb 28, 2001
DUAL LUMEN MIDLINE CATHETER
K010349 · LJS
Catheter Innovations, Inc.
General Hospital · 23d
Cleared Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP,...
K010444 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 14d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · MND
Olympus America, Inc.
Gastroenterology & Urology · 264d
Cleared Feb 27, 2001
DIAMOND ALOE VERA, STERILE
K002666 · MGQ
Medi-Tech Intl. Corp.
General & Plastic Surgery · 186d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102 · OCW
Pare Surgical, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 27, 2001
MEDIVISION IGS SYSTEM
K003699 · HAW
Medivision (U.S.A.), Inc.
Neurology · 88d
Cleared Feb 27, 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · JEY
Synthes (Usa)
Dental · 81d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 27, 2001
SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
K003946 · MOS
GE Medical Systems
Radiology · 68d
Cleared Feb 27, 2001
ENGPLUS
K010059 · GWN
Western Systems Research, Inc.
Neurology · 50d
Cleared Feb 27, 2001
PALFIQUE ESTELITE LV CLEAR
K010267 · EBF
Tokuyama America, Inc.
Dental · 29d