28 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INOMAX DSIR (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517564009·CoRoent Ant TLIF PEEK, 11x10x34mm 4°
LISTER BANDAGE SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896020450·LISTER BANDAGE SCISSORS
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802850·Anderson Retractor, 5 Prongs, 12cm
My Medical
FDA UDI
My Medical Store LLC·G4251103440·Anderson Claw Retractor
5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 26, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 2, 2015
IMPLANT, FIXATION DEVICE CONDYLAR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDP·February 23, 2017
ADJUSTABLE LARGE FIXATOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 12, 2026
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
FDA Recall
Open, Classified
·GE Healthcare·Product code LLZ·July 23, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare·September 25, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
FDA Recall
Open, Classified
·GE Healthcare·Product code LLZ·January 16, 2026
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare·March 11, 2026