11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
FDA 510(k)
FDA Class 2
·Cardiovascular
IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DPM 6/7 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code MHX·April 30, 2013
PULSE GEN MODEL 102
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·July 31, 2008
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 29, 2011
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 25, 2023
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 25, 2023
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 25, 2023
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012