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
27289–27312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2017
EMPOWR Porous Knee System
K171991 · MBH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Oct 04, 2017
Reprocessed Shavers/Burs
K172092 · HRX
Renovo, Inc.
Orthopedic · 85d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 77d
Cleared Oct 04, 2017
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
K172289 · FAD
Q Urological Corporation
Gastroenterology & Urology · 65d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d
Cleared Oct 04, 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile...
K172671 · GEI
Conmed Corporation
General & Plastic Surgery · 29d
Cleared Oct 04, 2017
Ultrasonic Generator
K172691 · LFL
Olympus Medical Systems Corp.
General & Plastic Surgery · 28d
Cleared Oct 03, 2017
Force Fiber Fusion Suture
K172016 · GAT
Teleflex Medical Incorporated
General & Plastic Surgery · 92d
Cleared Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · JXG
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Oct 03, 2017
Ablatherm Fusion
K172285 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
K172621 · JTN
Hardy Diagnostics
Microbiology · 33d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 03, 2017
Arisure Closed Vial Adapter
K172884 · LHI
Yukon Medical
General Hospital · 12d
Cleared Oct 02, 2017
Yooeehouse Breast Pump
K163183 · HGX
Nantong Poly Technology Co., Ltd.
Obstetrics & Gynecology · 322d
Cleared Oct 02, 2017
iSurg
K170054 · GEI
Jaco, LLC Dba Macan Manufacturing and...
General & Plastic Surgery · 269d
Cleared Oct 02, 2017
Nobilplast Denture Resin
K170375 · EBI
Cmp Industries, LLC
Dental · 237d
Cleared Oct 02, 2017
ECG Check - Universal, ECG Check - Universal Plus
K170506 · DXH
Cardiac Designs, Inc.
Cardiovascular · 223d
Cleared Oct 02, 2017
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque...
K170873 · EBF
Swissmeditec GmbH
Dental · 193d
Cleared Oct 02, 2017
BRIDALVEIL Occipital Cervical Thoracic System
K171250 · NKG
Astura Medical
Orthopedic · 157d
Cleared Oct 02, 2017
Trident® II Acetabular System
K171768 · LPH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 110d
Cleared Oct 02, 2017
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
K171978 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 94d
Cleared Oct 02, 2017
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder...
K172210 · KWS
Stryker Trauma AG
Orthopedic · 70d
Cleared Oct 02, 2017
Large Screws Range
K172596 · HWC
Newclip Technics
Orthopedic · 34d