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
75961–75984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 22, 2002
DEPILASE TWIN LASE LASER SYSTEM
K020412 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 22, 2002
PORTABLE X-RAY UNITS
K020436 · IZL
Sedecal., Sa.
Radiology · 14d
Cleared Feb 21, 2002
SPHYGMOCOR PX MODEL SCOR-PX
K012487 · DXN
Atcor Medical Pty, Ltd.
Cardiovascular · 203d
Cleared Feb 21, 2002
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET
K013241 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
K013252 · BWC
Cook, Inc.
Anesthesiology · 146d
Cleared Feb 21, 2002
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
K013862 · DQA
Bci, Inc.
Anesthesiology · 92d
Cleared Feb 21, 2002
PROVOX HME CASSETTE, MODEL 7240
K014102 · JOH
Atos Medical AB
Anesthesiology · 70d
Cleared Feb 21, 2002
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K020018 · MSX
Cardiopulmonary Corp.
Cardiovascular · 49d
Cleared Feb 21, 2002
MODIFICATION TO DATACAPTOR
K020197 · MWI
Capsule Technologie
Cardiovascular · 30d