13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ValPro 2 Plus, VaPro 2 Plus Pocket
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176618·Standard UHMWPE Insert - neutral
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575176625·Standard UHMWPE Insert - neutral
PINNACLE 300 ACET CUP 50MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 30, 2024
SILS PORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LOTUS II PULSED ER: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PLATE/8 HOLES/LEFT
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·June 21, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 17, 2014
PROXIMAL HUMERUS, LEFT, ÿ 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·May 30, 2024
ANN BLUNT TIP SCREW 4X52MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·May 30, 2024
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