20 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRIDLOCK PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CALIBRATION PLASMA LMW HEPARIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
NEEDLE NS 27GA 1IN BLT SQ GRD W/O SHLD
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 14, 2020
DRIVER, T10 HEXALOBE
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code MDM·December 16, 2025
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KWP·May 24, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 21, 2008
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 23, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 14, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 26, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 13, 2019
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2018
FLIPPER MREYE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2019
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·October 11, 2022
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018