21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CRAG LATERAL FLOW ASSAY (LFA)
FDA 510(k)
FDA Class 2
·Microbiology
Breast Basis Set 1,5T 3T
FDA UDI
Noras MRI products GmbH·04251269200151·
Gibralt
FDA UDI
Choice Spine, LP·00840996169424·GIBRALT,DRILL,FIXED,2.4X22
SPACELABS MEDICAL PATIENT MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
K-ASSAY D-DIMER CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
CM TITAMAX EX IMPLANT 3.5X9
FDA Adverse Event
Injury
·NEODENT JJGC S.A.·Product code DZE·November 9, 2017
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 28, 2011
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 3, 2026
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·September 1, 2020
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·August 28, 2018
NEEDLE, HYPODERMIC, SINGLE LUMEN
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 8, 2019
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·November 13, 2018
PERITX DRAINAGE BAG KIT
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·December 18, 2025
SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 6, 2024
PERITX DRAINAGE BAG
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code PNG·April 11, 2026
TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 2, 2022
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021