16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: WINNER ST-2 STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
QT-750
FDA UDI
CARESTREAM HEALTH, INC.·60889974000658·QT-750 QUIET-LIFT ELEV/FLOAT-TOP TABLE:
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613153170600·Drill for 6mm Screws, Dental Shaft
Endoscope Brushes
FDA UDI
HEALTHMARK INDUSTRIES CO., INC.·10848956001408·STANDARD ENDOSCOPE BRUSH & VALVE BRUSH
RESTORE PRIME
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 11, 2019
BIRD TBIRD LEGACY VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
BCI ADVISOR VITAL SIGNS MONITOR (9200)
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORE
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 7, 2012
NAV CD HORIZON® SOLERA¿ MAST 4.75 DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 20, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 10, 2011
PFC SIGMA FEM STEM BOLT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 13, 2008
RICH-MAR WINNER CM2
FDA Adverse Event
Injury
·RICH-MAR·Product code IPF·March 1, 2012
RESTORE PRIME
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 19, 2017
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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 REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024