10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541565·Ferreira Style Breast Retractor
90x30m...
MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Y-TZP POWDER AND PROCERA ALLZIRKON
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 2, 2013
IMRI MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
BD SYRINGE 3ML HEPARIN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NZW·September 9, 2019
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