13 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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CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177483·VuePoint Cross Conn, 3.5x54 Rod
MIZAR, BASIS BE, SANDMAN DIGITAL
FDA 510(k)
FDA Class 2
·Neurology
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EQUINOXE PRIMARY SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 18, 2026
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 29, 2016
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·June 30, 2014
TPS UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS, INSTRUMENTS DIV.·Product code ERL·November 26, 2012
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 13, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024