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
80137–80160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2000
ALL TERRAIN WHEELCHAIR (ATW)
K003048 · IOR
Roll-Ability (Pty) , Ltd.
Physical Medicine · 77d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · GEX
Laserscope
General & Plastic Surgery · 66d
Cleared Dec 15, 2000
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC)...
K003161 · LPL
Les Laboratoires Blanchard
Ophthalmic · 66d
Cleared Dec 15, 2000
RYTHMIC AND RYTHMIC UV
K003170 · LPL
Essilor Intl.
Ophthalmic · 66d
Cleared Dec 15, 2000
TRANSFX ANGLED RODS
K003205 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211 · LXT
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Dec 15, 2000
M2A 32MM TAPER SYSTEM
K003363 · KWY
Biomet, Inc.
Orthopedic · 49d
Cleared Dec 15, 2000
VIVANT BREAST LESION LOCALIZATION DEVICE
K003439 · KNW
Vivant Medical, Inc.
Gastroenterology & Urology · 39d
Cleared Dec 15, 2000
PROTRACT PRESS FIT HIP STEM
K003447 · LPH
Stelkast Company
Orthopedic · 39d
Cleared Dec 15, 2000
X-POSURE SYSTEM VERSION 2 MAMMO
K003656 · KGI
Pronosco A/S
Radiology · 18d
Cleared Dec 15, 2000
AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
K003711 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 14d
Cleared Dec 15, 2000
BIRD TBIRD LEGACY VENTILATOR
K003770 · CBK
Bird Products Corp.
Anesthesiology · 9d
Cleared Dec 15, 2000
ACE AIM TTC FUSION NAIL
K003797 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 7d
Cleared Dec 14, 2000
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS:...
K000834 · EFB
Castellini S.P.A.
Dental · 275d
Cleared Dec 14, 2000
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K002506 · CAH
Sims Portex, Inc.
General Hospital · 121d
Cleared Dec 14, 2000
PROCLUDE
K002989 · EJR
Ortek Therapeutics, Inc.
Dental · 80d
Cleared Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · DHA
Roche Diagnostics Corp.
Chemistry · 64d
Cleared Dec 14, 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228 · MKJ
Katecho, Inc.
Cardiovascular · 59d
Cleared Dec 14, 2000
CREATININE
K003247 · CGX
Jas Diagnostics, Inc.
Chemistry · 58d
Cleared Dec 14, 2000
METALYZER, MODEL 2
K993641 · BTY
Cortex Biophysik GmbH
Anesthesiology · 413d
Cleared Dec 14, 2000
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K994337 · MQV
Orthovita Co.
Orthopedic · 357d
Cleared Dec 13, 2000
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
K001233 · FPA
R-Group Intl.
General Hospital · 240d
Cleared Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
K001254 · JDQ
Orthomatrix, Inc.
Orthopedic · 238d
Cleared Dec 13, 2000
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · GWJ
Ics Medical Corp.
Neurology · 79d