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.

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

Filters: Cleared only ×
175,230 results
35329–35352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2015
CREO Stabilization System
K143633 · NKB
Globus Medical, Inc.
Orthopedic · 39d
Cleared Jan 29, 2015
TRANSONIC ELSA SYSTEM
K134051 · DXG
Transonic Systems, Inc.
Cardiovascular · 394d
Cleared Jan 29, 2015
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
K141210 · LLL
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Jan 29, 2015
LightStim for Acne/ LightStim for Acne Mini
K142246 · OLP
Led Intellectual Properties, LLC
General & Plastic Surgery · 168d
Cleared Jan 29, 2015
One Way Soft Valve
K142500 · MJJ
Terumo Cardiovascular Systems...
Cardiovascular · 146d
Cleared Jan 29, 2015
Surgical Gut Suture
K142656 · GAL
Covidien
General & Plastic Surgery · 133d
Cleared Jan 29, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K142714 · IYN
Sonoscape Company Limited
Radiology · 129d
Cleared Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K142837 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Jan 29, 2015
Mini ONE Enteral Extension Set
K142989 · PIF
Applied Medical Technology, Inc.
Gastroenterology & Urology · 105d
Cleared Jan 29, 2015
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler
K143129 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jan 29, 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155 · LBH
Johnson & Johnson Healthcare...
Dental · 87d
Cleared Jan 29, 2015
Capillus 272 Pro
K143199 · OAP
Capillus, LLC
General & Plastic Surgery · 84d
Cleared Jan 29, 2015
Ultimax-i
K143281 · OWB
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Jan 29, 2015
LOGIQ P9, LOGIQ P7
K143452 · IYN
Ge Healthcare
Radiology · 58d
Cleared Jan 28, 2015
WINSIX Implant System
K133733 · DZE
Biosaf IN S.R.L.
Dental · 418d
Cleared Jan 28, 2015
DCCERAM SYSTEM
K141400 · EIH
Ceramay GmbH & Co.Kg
Dental · 245d
Cleared Jan 28, 2015
QK-SYSTEMIC THERAPEUTIC APPARATUS
K141892 · ILY
Harbin Quanke Medi-Technical...
Physical Medicine · 198d
Cleared Jan 28, 2015
S22 Digital Color Doppler Ultrasound System
K142815 · IYN
Sonoscape Company Limited
Radiology · 121d
Cleared Jan 28, 2015
Endoskeleton TCS System
K142940 · OVE
Titan Spine, LLC
Orthopedic · 111d
Cleared Jan 28, 2015
Klassic BiPolar System
K143113 · KWY
Total Joint Orthopedics
Orthopedic · 90d
Cleared Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
K143691 · LBR
Roche Diagnostics Operations (Rdo)
Chemistry · 35d
Cleared Jan 27, 2015
NAUTILUS DELTA
K141634 · LJS
Romedex International Srl
General Hospital · 223d
Cleared Jan 27, 2015
SCHOELLY SINUSCOPE
K142249 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 166d
Cleared Jan 27, 2015
PANAVIA SA Cement Plus Automix
K142625 · EMA
Kuraray Noritake Dental, Inc.
Dental · 133d