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
49273–49296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 2010
MYOSURE ROD LENS SCOPE SEALS
K102686 · HIH
Interlace Medical, Inc.
Obstetrics & Gynecology · 28d
Cleared Oct 15, 2010
VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
K102774 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 21d
Cleared Oct 15, 2010
ELECTRONIC BLOOD PRESSURE MONITOR
K102920 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 14d
Cleared Oct 14, 2010
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)
K092593 · EWL
Atos Medical AB
Ear, Nose, Throat · 416d
Cleared Oct 14, 2010
ENDOSSEOUS DENTAL IMPLANT
K093562 · DZE
Southern Implants, Inc.
Dental · 330d
Cleared Oct 14, 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · KWQ
Spinal Elements, Inc.
Orthopedic · 105d
Cleared Oct 14, 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
K101864 · HRX
Medtronic
Orthopedic · 104d
Cleared Oct 13, 2010
SMALL PLATEAU SPACER SYSTEM
K093093 · ODP
Life Spine
Orthopedic · 377d
Cleared Oct 13, 2010
QUANTA FLASH H-TTG IGA
K094060 · MVM
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Oct 13, 2010
BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS
K100310 · MWJ
BTL Industries, Inc.
Cardiovascular · 252d
Cleared Oct 13, 2010
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND...
K100593 · GAW
Lsi Solutions, Inc.
General & Plastic Surgery · 225d
Cleared Oct 13, 2010
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K101149 · IYO
Ge Vingmed Ultrasound AS
Radiology · 173d
Cleared Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · JOX
Medtronic, Inc.
Hematology · 160d
Cleared Oct 13, 2010
COMPASS VASCULAR ACCESS
K101518 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 133d
Cleared Oct 13, 2010
REL-K ARTIFICAL LIMB PROSTHESIS
K101859 · ISY
Rizzoli Ortopedica S.P.A.
Physical Medicine · 103d
Cleared Oct 13, 2010
AIXPLORER
K102041 · ITX
Supersonic Imagine
Radiology · 86d
Cleared Oct 13, 2010
IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
K102325 · GDW
Covidien, LLC, Formerly Registered AS...
General & Plastic Surgery · 57d
Cleared Oct 12, 2010
EMCOOLSPAD
K100071 · NZE
Emcools Emergency Medical Cooling...
Cardiovascular · 274d
Cleared Oct 12, 2010
EXSALT WOUND DRESSING
K100580 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 224d
Cleared Oct 12, 2010
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
K101700 · HWC
Extremity Medical, LLC
Orthopedic · 117d
Cleared Oct 12, 2010
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO...
K101987 · NCX
Zoll Circulation
Neurology · 90d
Cleared Oct 12, 2010
IMAGYS
K102000 · LLZ
Keosys Sas
Radiology · 89d
Cleared Oct 12, 2010
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2
K102671 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Oct 08, 2010
REMEL SPECTRA MRSA
K092407 · JSO
Remel, Inc.
Microbiology · 428d