18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Magnetom Vida
FDA 510(k)
FDA Class 2
·Radiology
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176656·Standard UHMWPE Insert - neutral
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176670·Standard UHMWPE Insert - neutral
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 5, 2005
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
QUADRA-P FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
MPACT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025