26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Safety Insulin Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Cliniview 11
FDA UDI
PaloDEx Group Oy·06430035872350·
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 23, 2008
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 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
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
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