19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
FDA 510(k)
FDA Class 2
·Hematology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551032848·Electrohydr.Probe, 4.5 Fr., 10pcs
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000884574·AWL 7080911 FIXED ANGLE AWL
na
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994236098·AWL 7080911 FIXED ANGLE AWL
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608242·ALLEN, STERIS-AMSCO 4" STANDARD
MACROPORE OS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ADULT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·February 15, 2010
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OHJ·April 7, 2010
ATLANTIS TRANSLATIONAL SCREWS AND INSTR
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWJ·September 14, 2025
ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWJ·January 25, 2025
ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWJ·January 23, 2025
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code OHJ·April 7, 2010
V12 COVERED STENT
FDA Adverse Event
Malfunction
·ATRIUM MEDICLA CORP·Product code JCT·April 24, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·May 7, 2011
LATERALIZD HUM CUP DIA 36+6MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWS·July 22, 2008
IRE SINGLE ELECTRODE PROBE
FDA Adverse Event
Death
·ANGIODYNAMICS·Product code OHJ·April 9, 2010
ATLANTIS TRANSLATIONAL SCREWS AND INSTR
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HWJ·July 8, 2024
FIXED ANGLE AWL
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HWJ·December 11, 2025