18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NERVE LOCATOR/STIMULATOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Surgimedics®
FDA UDI
COASTAL LIFE TECHNOLOGIES, INC.·00814716020616·Smoke Evacuation Tubing
7-8MM MODULAR BIO-CORE DILATOR
FDA UDI
Biomet Orthopedics, LLC·00880304466814·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746100222·DB BKT MASTER UR CUSP 022 T=0 A+7 R=0
FRIOS®
FDA UDI
Dentsply Implants Manufacturing GmbH·07392532233685·MicroSaw Diamond Discs
Arthrex®
FDA UDI
ARTHREX, INC.·00888867316898·LOW PROFILE CORTICAL SCW, TI, 5.0x45MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111178528·5000 STD GRSP FCPS 45CM 5MM
O-RING PROSTHETIC ATTACHMENT DEVICE
FDA 510(k)
FDA Class 2
·Dental
HCG SOLID PHASE COMPONENT SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VAPR HOOK ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·September 25, 2009
NexGen® Complete Knee Solution
FDA UDI
Zimmer, Inc.·00889024202399·
NexGen® Complete Knee Solution
FDA UDI
Zimmer, Inc.·00889024202382·
NexGen® Complete Knee Solution
FDA UDI
Zimmer, Inc.·00889024202375·
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 27, 2014
TAXUS® LIBERTÉ® ATOM¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 9, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 22, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024