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
82705–82728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 13, 2000
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH,...
K000511 · GEI
Arthrocare Corp.
General & Plastic Surgery · 26d
Cleared Mar 13, 2000
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633
K000628 · MQE
Sims Portex , Ltd.
Obstetrics & Gynecology · 18d
Cleared Mar 13, 2000
CODMAN ETHISORB DURA PATCH
K991413 · GXQ
Johnson & Johnson Professionals, Inc.
Neurology · 325d
Cleared Mar 13, 2000
FERTILOSCOPY KIT FH 1.29/FTO 1.40
K992655 · HEW
Soprane S.A.
Obstetrics & Gynecology · 217d
Cleared Mar 13, 2000
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
K993024 · LJT
B. Braun of America, Inc.
General Hospital · 186d
Cleared Mar 13, 2000
HYLASINE
K993362 · EMX
Biomatrix, Inc.
Ear, Nose, Throat · 159d
Cleared Mar 13, 2000
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
K993568 · GWG
Machida Endoscope Co., Ltd.
Neurology · 144d
Cleared Mar 13, 2000
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS...
K994157 · DSP
Datascope Corp.
Cardiovascular · 95d
Cleared Mar 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d