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
83209–83232 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2000
THE HOMMED SENTRY, MODEL 1 SENTRY
K993938 · DXN
Hommed, LLC
Cardiovascular · 117d
Cleared Mar 15, 2000
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K994015 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 110d
Cleared Mar 15, 2000
BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
K994242 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 90d
Cleared Mar 15, 2000
CENTAUR SPINAL SYSTEM
K994347 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Mar 15, 2000
SYNTHES BUTTON PLATE
K994364 · MBI
Synthes (Usa)
Orthopedic · 79d
Cleared Mar 14, 2000
BARCOMED 5MP1H
K000014 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
BARCOMED 5MP2
K000016 · LLZ
Barco N.V.
Radiology · 71d
Cleared Mar 14, 2000
PARAPOST FIBER WHITE
K000311 · ELR
Coltene/Whaledent, Inc.
Dental · 42d
Cleared Mar 14, 2000
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 28d
Cleared Mar 14, 2000
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
K000554 · IYO
Quantel Medical
Radiology · 25d
Cleared Mar 14, 2000
MODEL 445SI-64E QUADRATURE WRIST COIL
K000589 · MOS
Igc-Medical Advances, Inc.
Radiology · 21d
Cleared Mar 14, 2000
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
K000675 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Mar 14, 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · KXK
Prostec, LLC
Radiology · 166d
Cleared Mar 14, 2000
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
K994254 · ETY
International Distributors of...
Ear, Nose, Throat · 88d
Cleared Mar 14, 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200...
K994285 · EHD
Dentsply Intl.
Radiology · 85d
Cleared Mar 14, 2000
BITEM LOCK, MODELS SW006, SW012
K994357 · EJF
Thermoelastic Technologies, Inc.
Dental · 78d
Cleared Mar 14, 2000
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
K994368 · LFC
American Dental Products, Inc.
Dental · 78d
Cleared Mar 14, 2000
SURGI-VISION ESOPHAGEAL STYLET COIL
K994436 · MOS
Surgi-Vision, Inc.
Radiology · 75d
Cleared Mar 13, 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
K000054 · KGN
Adri
General & Plastic Surgery · 66d
Cleared Mar 13, 2000
COMPUMEDICS E-SERIES EEG SYSTEM
K000068 · OLT
Compumedics Neuro Science Pty , Ltd.
Neurology · 63d
Cleared Mar 13, 2000
CBYON SURGICAL OPERATING SYSTEM (SOS)
K000171 · HAW
Cbyon, Inc.
Neurology · 53d
Cleared Mar 13, 2000
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
K000309 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 41d
Cleared Mar 13, 2000
CYNOSURE PHOTOGENICA VLS-STAR
K000490 · GEX
Cynosure, Inc.
General & Plastic Surgery · 27d
Cleared Mar 13, 2000
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
K000498 · GEX
Lumenis, Inc.
General & Plastic Surgery · 27d