42 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mimics inPrint
FDA 510(k)
FDA Class 2
·Radiology
SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
INTRABLOCK BIOBALL HIP SYSTEM (IBS)
FDA 510(k)
FDA Class 2
·Orthopedic
LUMINOS LOTUS MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·March 5, 2025
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 8, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 8, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 8, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 8, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 7, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 8, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·February 15, 2022
COLON DECOMPRESSION SET
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FEG·November 10, 2022
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 23, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 17, 2013
CNS-9700
FDA Adverse Event
NIHON KOHDEN CORP·Product code MHX·September 10, 2014
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
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 3, 2012
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 3, 2012
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2012