FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76465–76488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 26, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 13d
Cleared Feb 25, 2002
WAVELENGHT ULTRASOUND LOTION
K013212 · MUI
National Therapy Products, Inc.
Radiology · 153d
Cleared Feb 25, 2002
TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER
K013923 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 90d
Cleared Feb 25, 2002
AARON REUSABLE ELECTROSURGICAL ELECTRODE
K014201 · GEI
Aaron Medical Industries
General & Plastic Surgery · 66d
Cleared Feb 22, 2002
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · BSZ
Draeger Medical, Inc.
Anesthesiology · 290d
Cleared Feb 22, 2002
SPIRABRUSH CX BIOPSY INSTRUMENT
K011488 · HFB
Trylon Corp.
Obstetrics & Gynecology · 283d
Cleared Feb 22, 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · JEY
Bionx Implants, Inc.
Dental · 277d
Cleared Feb 22, 2002
BREATHING CIRCUIT FILTER
K012958 · CAH
Emergency Filtration Products, Inc.
General Hospital · 171d
Cleared Feb 22, 2002
BOND-1 C & B
K013543 · KLE
Jeneric/Pentron, Inc.
Dental · 128d
Cleared Feb 22, 2002
TORFLEX TRANSSEPTAL GUIDING SHEATH
K013919 · DBY
Baylis Medical Co., Inc.
Immunology · 87d
Cleared Feb 22, 2002
CP-SLEEVE
K013975 · KXK
Cp Medical
Radiology · 81d
Cleared Feb 22, 2002
NEOCALEX
K013993 · EIK
Stephen M Koral, Dmd
Dental · 80d
Cleared Feb 22, 2002
OPTIBOND SOLO PLUS 4
K014027 · KLE
Kerr Dental Materials Center
Dental · 78d
Cleared Feb 22, 2002
EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
K014033 · KPS
Syntermed, Inc.
Radiology · 77d
Cleared Feb 22, 2002
D.SIGN 84
K014042 · EJS
Ivoclar Vivadent, Inc.
Dental · 77d
Cleared Feb 22, 2002
DR. HAYS BITE GUARD
K014079 · MQC
Inventive Resources, Inc.
Dental · 73d
Cleared Feb 22, 2002
HARVEY PV DRY STERILIZER, MODEL # ST127325
K014174 · FLE
Barnstead/Thermolyne Corp.
General Hospital · 64d
Cleared Feb 22, 2002
TEMPHASE
K020092 · EBG
Kerr Dental Materials Center
Dental · 43d
Cleared Feb 22, 2002
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
K020161 · DQY
Guidant Corp.
Cardiovascular · 36d
Cleared Feb 22, 2002
SLIM GLIDING NAIL SYSTEM
K020240 · KTT
Plus Orthopedics
Orthopedic · 30d
Cleared Feb 22, 2002
INION CPS BSSO SCREW
K020266 · HWC
Inion , Ltd.
Dental · 28d
Cleared Feb 22, 2002
WMT MODULAR ULNAR HEAD IMPLANT
K020274 · KXE
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Feb 22, 2002
LORENZ BLUE DEVICE
K020407 · MQN
Walter Lorenz Surgical, Inc.
Dental · 16d