13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IODOFLEX
FDA 510(k)
FDA Unclassified
·Unknown
OsteoMed
FDA UDI
OSTEOMED LLC·00842528103678·7.0 x 55mm Cannulated Screw, 32mm Thd
OsteoMed
FDA UDI
OSTEOMED LLC·00842528108031·7.0 x 55mm Cann Screw 32Thd Sterile 2Pk
MALTA
FDA 510(k)
FDA Class 2
·Dental
BLUEPHASE STYLE
FDA 510(k)
FDA Class 2
·Dental
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 24, 2013
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 7, 2008
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·July 26, 2011
ENVEO PRO DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 14, 2024
ENVEO PRO DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 14, 2024
AVAN REINF RING SS 48/58MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 29, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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