11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ViewMate Multi Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
FDA 510(k)
FDA Class 2
·Anesthesiology
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
ENDOPATH XCEL TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·November 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 12, 2013
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
SEE H10
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 18, 2024
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018