27 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vivid iq
FDA 510(k)
FDA Class 2
·Radiology
SignaLoc Screw
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215116903·
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MOVATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·June 21, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 27, 2011
C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KNQ·September 30, 2008
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 17, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·September 29, 2021
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·June 3, 2022
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 15, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·January 30, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Injury
·COOK INC·Product code MMX·February 6, 2023
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·July 27, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 4, 2022
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·March 28, 2022
UNKNOWN JOINT REPAIR DEVICE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026