19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CLEARARCH
FDA 510(k)
FDA Class 2
·Dental
APEX
FDA 510(k)
FDA Class 2
·Radiology
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·May 5, 2021
KRD DEVICE, EMBOLIZATION, VASCULAR
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 19, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 20, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 11, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·July 31, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 25, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·February 3, 2020
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020