148 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TruMatch CMF Titanium 3D Printed Implant
FDA 510(k)
FDA Class 2
·Dental
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
FDA 510(k)
FDA Class 2
·Orthopedic
SPERMCHECK VASECTOMY
FDA 510(k)
FDA Class 2
·Hematology
LUMINOS LOTUS MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code OWB·March 5, 2025
TAXUS (R) LIBERTÉ (R)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 23, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·May 30, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code FGE·December 13, 2024
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 24, 2024
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·October 17, 2023
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code GBO·October 11, 2021
ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 1, 2024
ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 5, 2024
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·August 6, 2020