18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
FDA 510(k)
FDA Class 2
·Radiology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048438005613·Tubing Set, Suction LAP, S-PILOT
DR JOEL KAPLAN INC
FDA registration
DR JOEL KAPLAN INC·1 product·🇺🇸 United States
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IN SPACE 3D
FDA 510(k)
FDA Class 2
·Radiology
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 25, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·April 2, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 17, 2011
KNIGHTSTAR 330
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·April 18, 2008
PROLENE SUT 30IN(75CM) 6-0 BLU
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 2, 2023
PROLENE SUT 30IN(75CM) 6-0 BLU
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 2, 2023
PROLENE SUT 30IN(75CM) 6-0 BLU
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 2, 2023
PROLENE SUT 30IN(75CM) 6-0 BLU
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 2, 2023
PROLENE SUT 30IN(75CM) 6-0 BLU
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAW·May 2, 2023
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 11, 2016
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
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
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016