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
70609–70632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2003
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K032236 · LYZ
Est International Corporation
General Hospital · 36d
Cleared Aug 26, 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 35d
Cleared Aug 26, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K032272 · LYZ
Est International Corporation
General Hospital · 34d
Cleared Aug 26, 2003
DISPOSABLE N-PE MICKROKERATOME BLADES
K032297 · HNO
Oasis Medical, Inc.
Ophthalmic · 32d
Cleared Aug 26, 2003
MODIFICATION TO OUTBACK CATHETER
K032298 · DQY
Lumend, Inc.
Cardiovascular · 32d
Cleared Aug 26, 2003
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
K032376 · DQO
AngioDynamics, Inc.
Cardiovascular · 25d
Cleared Aug 25, 2003
VISUALINE METHADONE DIPSTRIPTEST
K023856 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 279d
Cleared Aug 25, 2003
NEUROTECH BAXOLVE TYPE 294
K023913 · GZJ
Bio-Medical Research, Ltd.
Neurology · 273d
Cleared Aug 25, 2003
MATCH PRESS PRESSABLE CERAMIC
K024250 · EIH
Davis Schottlander & Davis, Ltd.
Dental · 245d
Cleared Aug 25, 2003
SONIK LDI 20 AIR
K030374 · CAF
Evit Labs, Inc.
Anesthesiology · 202d
Cleared Aug 25, 2003
DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE
K030977 · DYH
Dentaurum
Dental · 150d
Cleared Aug 25, 2003
DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE
K030980 · DYH
Dentaurum
Dental · 150d
Cleared Aug 25, 2003
LYRA NASAL MASK
K031883 · BZD
Sensor Medics Corp.
Anesthesiology · 68d
Cleared Aug 25, 2003
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER...
K031921 · JJY
Cliniqa Corporation
Chemistry · 63d
Cleared Aug 25, 2003
EASY PULSE II OXYGEN CONSERVER
K032018 · NFB
Precision Medical, Inc.
Anesthesiology · 56d
Cleared Aug 25, 2003
MITEK MICRO QUICKANCHOR
K032078 · NOV
Mitek Worldwide
Orthopedic · 49d
Cleared Aug 25, 2003
STARBOND DENTAL BONDING ALLOYS
K032106 · EJT
Star Refining Precious Metals South...
Dental · 48d
Cleared Aug 25, 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203 · GKR
Hemocue, Inc.
Hematology · 38d
Cleared Aug 25, 2003
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
K032341 · EIA
Sota Precision Optics, Inc.
Dental · 27d
Cleared Aug 25, 2003
MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL
K032415 · MOS
Usa Instruments, Inc.
Radiology · 20d
Cleared Aug 25, 2003
3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL
K032474 · MOS
Usa Instruments, Inc.
Radiology · 13d
Cleared Aug 25, 2003
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
K032500 · KPS
Eclipse Systems, Inc.
Radiology · 12d
Cleared Aug 22, 2003
ANKYLOS
K012681 · DZE
Dentsply Ceramco
Dental · 738d
Cleared Aug 22, 2003
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · MGQ
Medtrade Products , Ltd.
General & Plastic Surgery · 382d