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
54097–54120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2009
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
K083388 · JEY
Synthes (Usa)
Dental · 115d
Cleared Mar 12, 2009
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
K090168 · HCG
MicroVention, Inc.
Neurology · 48d
Cleared Mar 11, 2009
BIOCLEAN CHEMO SHIELD
K081970 · LZA
Nitritex (M) Sdn. Bhd.
General Hospital · 244d
Cleared Mar 11, 2009
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
K082190 · GZJ
Bio-Medical Research, Ltd.
Neurology · 219d
Cleared Mar 11, 2009
LIFEPAK 15 MONITOR/DEFIBRILLATOR
K082937 · MKJ
Physio-Control, Inc.
Cardiovascular · 161d
Cleared Mar 11, 2009
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM,...
K083185 · FLL
Cadi Scientific Pte.Ltd
General Hospital · 133d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314 · DHB
Siemens Healthcare Diagnostics
Immunology · 121d
Cleared Mar 11, 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570 · CGA
Taidoc Technology Corporation
Chemistry · 98d
Cleared Mar 11, 2009
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K083625 · JCT
Alveolus, Inc.
General & Plastic Surgery · 93d
Cleared Mar 11, 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · HSB
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Mar 11, 2009
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
K083738 · DQX
Abbott Vascular
Cardiovascular · 85d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · LZO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...
K083906 · NDY
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Mar 11, 2009
SOFTSEAL-STF
K090100 · QSY
Chitogen, Inc.
General & Plastic Surgery · 55d
Cleared Mar 11, 2009
GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL...
K090124 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 49d
Cleared Mar 11, 2009
SEDECAL, MILLENNIUM PLUS
K090279 · KPR
Sedecal., Sa.
Radiology · 35d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 11, 2009
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)
K090325 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Mar 11, 2009
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2,...
K090374 · LXT
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Mar 10, 2009
DYNAMIPEAK PEAK FLOW METER
K082899 · BZH
Dynamitech Medical, Inc.
Anesthesiology · 161d
Cleared Mar 10, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · LYZ
Zibo Goldenline Plastic Product Co.,...
General Hospital · 152d
Cleared Mar 10, 2009
LOUSEBUSTER
K083206 · LJL
Larada Sciences
General Hospital · 130d
Cleared Mar 10, 2009
ADX4000-L, DX3000-L
K083532 · MUH
Dexcowin Co., Ltd.
Radiology · 102d
Cleared Mar 10, 2009
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
K083677 · DRX
Commwell , Ltd.
Cardiovascular · 89d