16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292817·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012559·K-Wires, Single trocar, .045-inch (1.1mm) diame...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049132·K-Wires, Single trocar, .045-inch (1.1mm) diame...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111124839·ROCH-CARMALT FCP CVD 6 1/4"
SLIM ONEBODY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·April 3, 2019
ASCENDRA INTRODUCER SHEATH SET
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·June 14, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 1, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·September 19, 2014
OPEN-END FLEXI-TIP URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 6, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·February 7, 2020
OPEN-END URETERAL CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KOD·December 5, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018