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

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176,076 results
56929–56952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2008
PHYSIOFLOW SYSTEM
K060387 · DSB
Vasocom, Inc.
Cardiovascular · 786d
Cleared Apr 10, 2008
ELEGANCE WOMAN'S LUBRICANT
K070587 · NUC
Julie Williams, Pa-C
Obstetrics & Gynecology · 406d
Cleared Apr 10, 2008
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL
K071524 · MQX
Tcm World, Inc.
General Hospital · 311d
Cleared Apr 10, 2008
BOVIE IDS-400 ELECTROSURGICAL GENERATOR
K072041 · GEI
Bovie Medical
General & Plastic Surgery · 260d
Cleared Apr 10, 2008
GBI TSH NEONATAL SCREENING KIT
K072458 · JLW
Golden Bridge International, Inc.
Chemistry · 223d
Cleared Apr 10, 2008
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL...
K073219 · FTM
American Medical Systems, Inc.
General & Plastic Surgery · 147d
Cleared Apr 10, 2008
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
K073590 · OIF
Kronus Market Development Associates,...
Immunology · 112d
Cleared Apr 10, 2008
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
K073648 · CGA
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Apr 10, 2008
INTREPID SPINAL SYSTEM
K080083 · MAX
Medtronic Sofamor Danek
Orthopedic · 90d
Cleared Apr 10, 2008
COOLTOUCH MODELS LC215 AND COOLLIPO
K080163 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 78d
Cleared Apr 10, 2008
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH...
K080185 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 76d
Cleared Apr 10, 2008
BAHA CORDELLE II
K080363 · MAH
Cochlear Bone Anchored Systems AB
Ear, Nose, Throat · 59d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · JDO
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
K080850 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 15d
Cleared Apr 10, 2008
CHROMOPHARE E-SERIES
K080857 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 14d
Cleared Apr 09, 2008
MODIFICATION TO:SPECIALTY NEEDLES
K073222 · BSP
Busse Hospital Disposables, Inc.
Anesthesiology · 146d
Cleared Apr 09, 2008
PHARAON LIPO
K073617 · GEX
Osyris
General & Plastic Surgery · 105d
Cleared Apr 09, 2008
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
K073695 · JAK
J. Morita USA, Inc.
Radiology · 100d
Cleared Apr 09, 2008
PASS SPINAL SYSTEM
K080099 · MNI
Medicrea Technologies
Orthopedic · 86d
Cleared Apr 09, 2008
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
K080132 · FER
Thd Spa
Gastroenterology & Urology · 82d
Cleared Apr 09, 2008
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE...
K080226 · HGM
Hill-Rom Manufacturing, Inc.
Obstetrics & Gynecology · 71d
Cleared Apr 09, 2008
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
K080410 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 55d
Cleared Apr 09, 2008
IMAGENMD WITH IMAGENQ
K080770 · LLZ
Cardiovascular Imaging Technologies, LLC
Radiology · 22d
Cleared Apr 09, 2008
RTM AND OVAL
K080880 · IOR
Next Mobility, LLC
Physical Medicine · 9d