13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SBI SR MTP TOE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
FDA 510(k)
FDA Class 2
·Cardiovascular
DW 276 #3
FDA 510(k)
FDA Class 2
·Dental
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 28, 2025
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 28, 2025
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2021
ATRICURE BIPOLAR SYSTEM
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·July 28, 2010
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code OUT·April 23, 2013
THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·August 21, 2014
SPIDER - SINGLE PORT SURGICAL DEVICE
FDA Adverse Event
Malfunction
·TRANSENTERIX INC.·Product code GCJ·April 13, 2011
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
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