12 results
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19ms
·
Sources: EU EUDAMED, US FDA
KODATROL I AND II CONTROL AND DILUENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Cutting Reamer
FDA UDI
Biomet Orthopedics, LLC·00887868556685·
8MM CUTTING REAMER
FDA UDI
Biomet Orthopedics, LLC·00880304464001·
PUR Prosthetic Screw 0.048 Hex
FDA UDI
STERNGOLD DENTAL LLC·00841549113505·PUR Prosthetic Screw 0.048 Hex. PUR Prosthetic...
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·00840117408647·
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400327·
CHALLENGE 5000 POWERED MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
MAGNETIC RESONANCE DEVICE MRT 150A
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 9, 2013
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-CLONMEL·Product code NIQ·November 22, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWS·July 1, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015