23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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I-STAT CREATINE KINASE MB (CK-MB)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58210514330·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
CNS-9300 SERIES CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
BALLERT CRANIAL MOLDING HELMET
FDA 510(k)
FDA Class 2
·Neurology
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013
SECURE ACUTE CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 4, 2011
STONETOME STONE REMOVAL DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FDI·May 21, 2008
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 2, 2020
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 2, 2020
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 2, 2020
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 2, 2020
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·January 2, 2020
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·November 16, 2019
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·November 16, 2019
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·November 16, 2019
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·November 16, 2019
C/HESIVE NAT WFR FLEX 19/45MM (1X5)GB/NL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·November 16, 2019
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012