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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142129–142152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1986
CAULK'S POLISHING PASTE
K863174 · EBF
Dentsply Intl.
Dental · 50d
Cleared Oct 07, 1986
DURA NEB(TM) 2000 PORTABLE COMPRESSOR
K863339 · BTI
Thera Tec, Inc.
Anesthesiology · 40d
Cleared Oct 07, 1986
CANNON NASAL SPLINT
K863382 · EPP
Treace Medical, Inc.
Ear, Nose, Throat · 34d
Cleared Oct 07, 1986
SUCTION-OFF
K863653 · HXD
B&B Medical Technologies, Inc.
General & Plastic Surgery · 19d
Cleared Oct 07, 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · FRN
C.R. Bard, Inc.
General Hospital · 18d
Cleared Oct 07, 1986
ABNORMAL SPINAL FLUID CONTROL
K863745 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 13d
Cleared Oct 07, 1986
ORTHO-BITE WAX WAFER
K863758 · EGD
Columbus Dental Mfg. Co.
Dental · 12d
Cleared Oct 06, 1986
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · GWM
Codman & Shurtleff, Inc.
Neurology · 392d
Cleared Oct 06, 1986
FEMORAL HEMI-HIP PROSTHESIS
K862460 · KWY
Orthopaedic Device Corp.
Orthopedic · 98d
Cleared Oct 06, 1986
SLEEP ANALYZING COMPUTER
K862527 · OLZ
Micro Tronics Corp.
Neurology · 96d
Cleared Oct 06, 1986
MULTISTIM(4-CHANNEL), MULTISTIM-OCTRODE(8 CHANNEL)
K862915 · GZB
Neuromed, Inc.
Neurology · 66d
Cleared Oct 06, 1986
ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY
K863028 · DZE
Ross Implant Technologies Corp., Inc.
Dental · 56d
Cleared Oct 06, 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · DSI
Quinton, Inc.
Cardiovascular · 49d
Cleared Oct 06, 1986
SIREDOC 60 AND SIREDOC 220
K863331 · DSF
Siemens Medical Solutions USA, Inc.
Cardiovascular · 40d
Cleared Oct 06, 1986
SUCTION CATHETER KIT
K863497 · BSY
Welmed Systems, Inc.
Anesthesiology · 27d
Cleared Oct 06, 1986
CO2 LASER MICROMANIPULATOR
K863520 · HHR
Laser Spectrum, Inc.
Obstetrics & Gynecology · 26d
Cleared Oct 06, 1986
THACKRAY CRUCIATE SPARING KNEE CS-1
K863554
Thackray USA
Orthopedic · 24d
Cleared Oct 06, 1986
BLADE, SURGICAL PREPARATION RAZOR, STRAIGHT,SINGLE
K863557
American Safety Razor Co.
General & Plastic Surgery · 24d
Cleared Oct 06, 1986
PALS
K863621 · FMK
West Lake Marketing
General & Plastic Surgery · 20d
Cleared Oct 06, 1986
UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS
K863636
Biological & Environmental Control...
General & Plastic Surgery · 19d
Cleared Oct 06, 1986
SALTER VOLUCHEK 6600
K863656 · BZG
Salter Labs
Anesthesiology · 18d
Cleared Oct 06, 1986
SALTER LABS 3000 SERIES PERCUSSORS
K863658 · BYI
Salter Labs
Anesthesiology · 18d
Cleared Oct 06, 1986
TRADITION HIGH SPEED HANDPIECE
K863677 · EFB
Midwest
Dental · 17d
Cleared Oct 06, 1986
TECA/ECEM T5 PORTABLE ELECTROENCEPHALOGRAPH
K863749 · GWQ
Teca, Inc.
Neurology · 12d