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
51937–51960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2009
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
K092361 · LIT
Invatec S.P.A.
Cardiovascular · 86d
Cleared Oct 29, 2009
PTFE PEELABLE INTRODUCER
K093023 · DYB
Great Batch Medical
Cardiovascular · 30d
Cleared Oct 29, 2009
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
K093251 · GEX
Omniguide, Inc.
General & Plastic Surgery · 13d
Cleared Oct 28, 2009
GIVEN ELECTROSURGICAL NEEDLE
K082584 · GEI
Tripps Court Enterprises, Inc.
General & Plastic Surgery · 415d
Cleared Oct 28, 2009
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL...
K091284 · GGN
Affinity Biologicals, Inc.
Hematology · 180d
Cleared Oct 28, 2009
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K091433 · JPK
R&D Systems, Inc.
Hematology · 168d
Cleared Oct 28, 2009
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
K091566 · HSB
Zimmer GmbH
Orthopedic · 153d
Cleared Oct 28, 2009
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
K091726 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 139d
Cleared Oct 28, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K091984 · DHB
Siemens Medical Solutions Diagnostics
Immunology · 118d
Cleared Oct 28, 2009
NORM SPINAL SYSTEM
K092011 · MNH
Norm Tibbi Urunler Ithalat Ihracat...
Orthopedic · 114d
Cleared Oct 28, 2009
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100
K092245 · DXQ
Honsun (Nantong) Co., Ltd.
Cardiovascular · 92d
Cleared Oct 28, 2009
CHECKPOINT
K092292 · ETN
Ndi Medical, LLC
Ear, Nose, Throat · 91d
Cleared Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
K092926 · KGN
Acell, Inc.
General & Plastic Surgery · 35d
Cleared Oct 28, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35,...
K093002 · KRD
MicroVention, Inc.
Cardiovascular · 30d
Cleared Oct 27, 2009
LOW & HIGH SPEED KIT
K090055 · EFA
Dpm USA Corp.
Dental · 292d
Cleared Oct 27, 2009
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · HRS
Tornier, Inc.
Orthopedic · 279d
Cleared Oct 27, 2009
NAVILAS LASER SYSTEM
K091064 · HQF
Od-Os GmbH
Ophthalmic · 196d
Cleared Oct 27, 2009
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR
K091174 · JOJ
STERIS Corporation
General Hospital · 188d
Cleared Oct 27, 2009
GRS GLENOID RESURFACING SYSTEM
K091196 · KWS
Arthrosurface, Inc.
Orthopedic · 187d
Cleared Oct 27, 2009
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
K091446 · ONG
Palomar Medical Products, Inc.
General & Plastic Surgery · 165d
Cleared Oct 27, 2009
FLUID ISOLATION DEVICE
K091915 · HQC
Lenstec, Inc.
Ophthalmic · 119d
Cleared Oct 27, 2009
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150 · LOD
Biomet, Inc.
Orthopedic · 103d
Cleared Oct 27, 2009
CLEARFIL MAJESTY POSTERIOR PLT
K092281 · EBF
Kuraray Medical, Inc.
Dental · 90d
Cleared Oct 27, 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 90d