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
76585–76608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2002
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
K013300 · GEX
Technology Delivery Systems, Inc.
General & Plastic Surgery · 195d
Cleared Apr 16, 2002
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
K013621 · FPA
Becton Dickinson Infusion Therapy...
General Hospital · 162d
Cleared Apr 16, 2002
ACTICHROME HEPARIN (ANTI-FIIA)
K013637 · KFF
American Diagnostica, Inc.
Hematology · 162d
Cleared Apr 16, 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · MQP
Synthes (Usa)
Orthopedic · 89d
Cleared Apr 16, 2002
CHIN ELECTRODE
K020468 · GXY
Dymedix, Inc.
Neurology · 63d
Cleared Apr 16, 2002
INTRASTENT LD (LARGE DIAMETER) STENT
K020528 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · KLS
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Apr 16, 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 22d
Cleared Apr 16, 2002
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM
K020963 · MEH
Biomet Orthopedics, Inc.
Orthopedic · 22d
Cleared Apr 16, 2002
COBRA COOLED SURGICAL PROBE, MODEL 1596X
K021046 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Apr 16, 2002
PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307
K021076 · FXX
Primeline Medical Products, Inc.
General Hospital · 13d
Cleared Apr 15, 2002
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
K003916 · IMB
Scandia Manufacturing , Ltd.
Physical Medicine · 482d
Cleared Apr 15, 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · KWP
United States Surgical, A Division of...
Orthopedic · 90d
Cleared Apr 15, 2002
ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM
K020145 · LPH
Orthopaedic Innovations, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
SERRALNYL
K020146 · GAR
Serral, S.A. DE C.V.
General & Plastic Surgery · 89d
Cleared Apr 15, 2002
CONSENSUS ACETABLAR SHELL, TI COATED
K020153 · LPH
Hayes Medical, Inc.
Orthopedic · 89d
Cleared Apr 15, 2002
L.A.M. IPM WOUND GEL
K020325 · MGQ
L.A.M. Pharmaceutical, Corp.
General & Plastic Surgery · 74d
Cleared Apr 15, 2002
WOUND PROTECTOR/RETRACTOR
K020435 · KKX
Applied Medical Resources Corp.
General Hospital · 66d
Cleared Apr 15, 2002
CARESIDE TRGLYCERIDE
K020488 · CDT
Careside, Inc.
Chemistry · 61d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517 · MNI
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · GGC
Bio-Rad
Hematology · 28d
Cleared Apr 15, 2002
NBX - NON-BRIDGING EXTERNAL FIXATOR
K020905 · LXT
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Apr 12, 2002
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
K011903 · DQK
Vivometrics, Inc.
Cardiovascular · 298d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d