FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
75457–75480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890 · DQO
St Jude Medical
Cardiovascular · 29d
Cleared Apr 17, 2002
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X
K020940 · GAW
Sutura, Inc.
General & Plastic Surgery · 26d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · FRN
Smith & Nephew, Inc.
General Hospital · 23d
Cleared Apr 17, 2002
NICOLET ELECTROCAUTERY DETECTOR
K020955 · ETN
Nicolet Biomedical, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 17, 2002
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K021049 · OWB
Ge Oec Medical Systems
Radiology · 16d
Cleared Apr 17, 2002
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
K021077 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · FOZ
Micro Therapeutics, Inc.
General Hospital · 8d
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