Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
60601–60624 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372 · DQX
Terumo Medical Corp.
Cardiovascular · 72d
Cleared Jan 19, 2007
MOORLDLS LASER DOPPLER LINE SCANNER
K063561 · DPT
Moor Instruments, Ltd.
Cardiovascular · 53d
Cleared Jan 19, 2007
VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE
K063597 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jan 19, 2007
ACE BOND SE
K063780 · KLE
Bisco, Inc.
Dental · 29d
Cleared Jan 19, 2007
ACCIN UNI-KNEE SYSTEM
K063782 · HSX
Accin Corporation
Orthopedic · 29d
Cleared Jan 19, 2007
SPIDERFX EMBOLIC PROTECTION DEVICE
K063785 · NFA
Ev3, Inc.
Cardiovascular · 29d
Cleared Jan 19, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K070006 · LYZ
Zibo Hengde Plastic & Rubber Products...
General Hospital · 16d
Cleared Jan 18, 2007
HAIRMAX LASERCOMB
K060305 · OAP
Lexington International, LLC
General & Plastic Surgery · 346d
Cleared Jan 18, 2007
NUVASIVE ACP4 SYSTEM
K062590 · KWQ
Nuvasive, Inc.
Orthopedic · 139d
Cleared Jan 18, 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · DQO
Vascular Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 18, 2007
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
K063211 · JWH
Stelkast Company
Orthopedic · 87d
Cleared Jan 18, 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063417 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared Jan 18, 2007
MICROPLASTY TIBIAL TRAYS
K063732 · JWH
Biomet Manufacturing Corp
Orthopedic · 31d
Cleared Jan 17, 2007
PREMIO
K060465 · MXW
Peters Surgical
General & Plastic Surgery · 329d
Cleared Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
K062009 · JXG
Aesculap, Inc.
Neurology · 184d
Cleared Jan 17, 2007
MODIFICATION TO VECTORVISION TRAUMA
K062358 · HAW
Brainlab AG
Neurology · 156d
Cleared Jan 17, 2007
BWF-5 MEDICAL LASER SERIES, 810 NM
K062363 · GEX
B&W Tek, Inc.
General & Plastic Surgery · 160d
Cleared Jan 17, 2007
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 111d
Cleared Jan 17, 2007
SOCK IT! ORAL PAIN GEL
K063148 · OLR
Merlin Group Dba Mcmerlin Dental Company
General & Plastic Surgery · 93d
Cleared Jan 17, 2007
BEAMAX
K063249 · GEX
Medic Sharplight , Ltd.
General & Plastic Surgery · 83d
Cleared Jan 17, 2007
VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
K063396 · GEX
Lasering S.R.L.
General & Plastic Surgery · 69d
Cleared Jan 17, 2007
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
K063429 · HFX
Generic Medical Device, Inc.
Obstetrics & Gynecology · 65d
Cleared Jan 17, 2007
VSPSPN
K063438 · NDN
Tecres S.P.A.
Orthopedic · 64d
Cleared Jan 17, 2007
TROCASYS
K063528 · GCJ
PAJUNK GmbH Medizintechnologie
General & Plastic Surgery · 56d