25 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blood Collection Accessory (BUCA)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BLUE SUI SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUADRA-P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
MANUAL ORTHOPEDIC SURICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code LXH·September 18, 2008
VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024
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
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·June 3, 2022
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025
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