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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EQUALIZER OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128008·20-30 MV FOR MEN SEL EW CLF STD GREY III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129371·20-30 MV FOR MEN CLSC EW STD GREY III
POTTS-NEVINS FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896023420·POTTS-NEVINS FORCEPS TUNGSTEN CARBIDE SERRATED TIP
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052474·Micro-Mosquito Hemostatic Forceps
1x2 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052467·Micro-Mosquito Hemostatic Forceps
1x2 te...
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019
INSTAFLO BOWEL CATHETER SYSTEM KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD LUER-LOK¿ 3ML W/NDL
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 6, 2022
PRIMO
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILJ·May 24, 2013
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 27, 2011
PARIETEX COMP 20X15CM OS VERSION X1
FDA Adverse Event
Injury
·TREVOUX - USS·Product code FTL·August 29, 2008
33 CM PKS PLASMASPATULA W/CORD (5/PK)
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEI·December 23, 2019
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024