14 results · 21ms · Sources: EU EUDAMED, US FDA

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ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Gauthier Biomedical

FDA UDI
GAUTHIER BIOMEDICAL, INC.·00858325005169·Low Torque T-Handle (Distributor Part Number 25...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197055512·Faure Perritoneal Forceps Fig. 2 1x2 te...

BLOOD PRESSURE METER MODEL CH-101

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO ACCULEAF

FDA 510(k)
FDA Class 2 ·Radiology

COCR BALL HEAD 12/14 Ø 36 SIZE L +3.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 3, 2016

MPACT ACETABULAR PE LINER Ø 36

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·October 15, 2015

MAGELLAN INSULIN 1ML 29GX1/2"

FDA Adverse Event
Malfunction ·COVIDIEN·Product code FMF·June 13, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2013

HIRES 90K

FDA Adverse Event
Malfunction ·ADVANCED BIONICS LLC·Product code MCM·August 28, 2008

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

GALAFLEX

FDA Adverse Event
Injury ·TEPHA, INC·Product code OOD·February 28, 2020

MPACT MULTI HOLES SHELL

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 2, 2016

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