20 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Yomi Robotic System
FDA 510(k)
FDA Class 2
·Dental
Symmetry Cone
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001257·Symmetry® Curette, Cone Ring, Angled, Size 3, 9...
Advantage Trial Inserter
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215067915·
Encision AEM enTouch 2X Scissor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOGEL PAD
FDA 510(k)
FDA Class 2
·Radiology
IMP,TSV,4.1MM,SBM,8
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 31, 2020
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·October 15, 2014
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·October 28, 2008
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 18, 2014
LASSOSTAR NAV CIRCULAR MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DRF·October 19, 2023
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019