13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·September 29, 2025
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286669·Orthopaedic prosthesis instrument, reusable - G...
LINK Instruments - Rasps, compressors and broaches
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575286423·Orthopaedic prosthesis instrument, reusable - G...
BICERA (TM) RESORBABLE BONE SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
REAMER Ø11 F/PFNA BLADE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·May 24, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 30, 2014
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 25, 2018
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
FDA Enforcement
Class I
·Ongoing·Edwards Lifesciences, LLC·July 16, 2025
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018