19 results · 23ms · Sources: EU EUDAMED, 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