15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TriMed Threaded Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
BD BBL™ Sensi-Disc™ Colistin - 10 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·00382902307495·BD BBL™ Sensi-Disc™ Colistin 10 µg
BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·July 31, 2023
CUBEScan BioCon-900S
FDA 510(k)
FDA Class 2
·Radiology
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR
FDA 510(k)
FDA Class 2
·Radiology
BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·August 27, 2025
BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·August 27, 2025
BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·August 29, 2025
BD BBL¿ SENSI-DISC¿ COLISTIN - 10 ¿G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·August 27, 2025
PEAK FX KEY ASSY NS
FDA Adverse Event
Malfunction
·DEPUY ACE S.A. 'R.L·Product code KTT·October 27, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 1, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code JKA·November 7, 2018
BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 15, 2021
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