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
80641–80664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2000
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · KWP
Depuyacromed
Orthopedic · 105d
Cleared Dec 15, 2000
REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K002747 · LPH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052,...
K002906 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Dec 15, 2000
MTG - MINITUB HEATED STAGE SYSTEMS
K002971 · MQG
Zander Medical Supplies, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 15, 2000
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
K002972 · KHJ
Medtronic Xomed
Ear, Nose, Throat · 84d
Cleared Dec 15, 2000
GRAMS SILK NONABSORBABLE SUTURE
K003001 · GAP
Gramsmed, LLC
General & Plastic Surgery · 80d
Cleared Dec 15, 2000
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
K003015 · GAN
Surgical Specialties Corp
General & Plastic Surgery · 79d
Cleared Dec 15, 2000
TITAN TIBIAL NAIL
K003018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 79d
Cleared Dec 15, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE,...
K003038 · OLW
Agilent Technologies Deutschland GmbH
Neurology · 77d
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