15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IR Type Implant System
FDA 510(k)
FDA Class 2
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292916·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012672·K-Wires, Single trocar, .062-inch (1.6mm) diame...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049286·K-Wires, Single trocar, .062-inch (1.6mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484467·K-Wire w. trocar/round end _x000D_...
K-Wire w. trocar/round end 1.57mm/152mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711850·K-Wire w. trocar/round end
1.57mm...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 6, 2022
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·June 14, 2013
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·July 1, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 22, 2008
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