26 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
FDA 510(k)
FDA Class 2
·Immunology
CONEXA
FDA Adverse Event
LIFECELL CORPORATION·Product code FTM·August 16, 2011
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 27, 2008
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR
FDA Adverse Event
Injury
·BARD SHANNON LIMITED·Product code OTP·July 2, 2013
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 18, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·May 20, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·June 10, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 13, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 11, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023
NANOZOOMER S360 (THIS IS AN IVDD PRODUCT, NOT SOLD IN THE U.S.)
FDA Adverse Event
Malfunction
·HAMAMATSU PHOTONICS K.K, SYSTEMS DIVISION,·Product code PSY·June 5, 2023
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·November 12, 2024
SNAPLOC WIRE GUIDE LOCKING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code ODC·December 16, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023
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
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