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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48697–48720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2010
RESTORELLE POLYPROPYLENE MESH
K103568 · FTL
Coloplast A/S
General & Plastic Surgery · 16d
Cleared Dec 21, 2010
GEOSOURCE
K092844 · OLX
Electrical Geodesics, Inc.
Neurology · 462d
Cleared Dec 21, 2010
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A
K100451 · MPB
Gambro Renal Products, Inc.
Gastroenterology & Urology · 307d
Cleared Dec 21, 2010
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
K100703 · MQB
Comed Co., Ltd.
Radiology · 284d
Cleared Dec 21, 2010
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
K100790 · JPK
Beckman Coulter, Inc.
Hematology · 274d
Cleared Dec 21, 2010
CARRIGEN
K100883 · LYC
Etex Corp.
Dental · 266d
Cleared Dec 21, 2010
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937 · NBW
I-Sens, Inc.
Chemistry · 260d
Cleared Dec 21, 2010
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
K101715 · KDI
Fresenius Medical Care North America,...
Gastroenterology & Urology · 186d
Cleared Dec 21, 2010
MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
K101982 · DTA
St Jude Medical, Crmd
Cardiovascular · 160d
Cleared Dec 21, 2010
TARGON FN SYSTEM
K102057 · KTT
Aesculap Implant Systems, LLC
Orthopedic · 152d
Cleared Dec 21, 2010
OSOM C. DIFFICILE TOXIN A/B TEST
K102242 · LLH
Genzyme Corporation
Microbiology · 134d
Cleared Dec 21, 2010
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410 · HWC
Conmed Linvatec
Orthopedic · 119d
Cleared Dec 21, 2010
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
K102549 · LZJ
Ascension Orthopedics, Inc.
Orthopedic · 105d
Cleared Dec 21, 2010
LIPID CONTROLS
K102700 · JJY
Alere, San Diego, Dba Biosite...
Chemistry · 92d
Cleared Dec 21, 2010
FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST &...
K102770 · ELW
Heraeus Kulzer, LLC
Dental · 88d
Cleared Dec 21, 2010
NEUROVISION SE (NERVEANA)
K102862 · ETN
Neurovision Medical Products, Inc.
Ear, Nose, Throat · 82d
Cleared Dec 21, 2010
2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
K102966 · LJS
Medcomp
General Hospital · 77d
Cleared Dec 21, 2010
SONIXTABLET ULTRASOUND SCANNER
K102997 · IYN
Ultrasonix Medical Corporation
Radiology · 75d
Cleared Dec 21, 2010
LEKSELL GAMMAPLAN
K103093 · MUJ
Elekta Instrument AB
Radiology · 63d
Cleared Dec 21, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
K103223 · OIY
Encore Medical, L.P.
Orthopedic · 50d
Cleared Dec 21, 2010
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
K103502 · NQI
Veridex, LLC
Pathology · 22d
Cleared Dec 20, 2010
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
K090324 · HEX
Sti Medical Systems
Obstetrics & Gynecology · 679d
Cleared Dec 20, 2010
SYNTHES ZERO-P
K093762 · OVE
Synthes Spine
Orthopedic · 378d
Cleared Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · GGN
Dade Behring, Inc.
Hematology · 369d