57 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LIAISON 25 TOTAL-D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024240·BL80 ITCD, L BE BLISS 80
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260455·BONE MARROW & ASPIRATION TRAY 11G X 4", STYLE 3
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780429685·Bone Marrow & Aspiration Tray 11G X 4", Style 3
BLOOD PRESSURE MONITOR, MODEL KP-7000
FDA 510(k)
FDA Class 2
·Cardiovascular
P200MAAF
FDA 510(k)
FDA Class 2
·Ophthalmic
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
STRYKER NAV3(TM) PLATFORM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·May 29, 2013
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·June 17, 2011
FLEXOR RADIAL ACCESS SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·April 13, 2015
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·July 18, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 3, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·September 4, 2025