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