16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PathLoc SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772826322·LUMBAMED SACRO, GREY, I
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021039·FM2 - Embla
n/a
FDA UDI
Ortho Development Corporation·00822409070770·Snap-On Fem Aug Trial 2mm Posterior Sz 4
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AXERA 2 ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
UNKNOWN DEPUY METAGLENE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. - REG. 1818910·Product code KWS·July 22, 2013
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·June 21, 2021
INSULIN PUMP
FDA Adverse Event
Malfunction
·UNKNOWN·Product code LZG·August 22, 2024
DEXCOM G7
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
OT VERIO2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2017
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023