14 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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CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
FDA 510(k)
FDA Class 2
·Orthopedic
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187396·Battalion, LLIF Trial, 15°, 18 mm Wide, 17 mm X...
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
GLO-SPEC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BRIDGE FX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 30, 2024
T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HXX·April 2, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 28, 2011
PFC SIGMA STB INS S2.5 22.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC., DEPUY -RAYNHAM·Product code JWH·April 17, 2008
VAC PAC SIZE 30
FDA Adverse Event
Injury
·NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.·Product code CCX·August 29, 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
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016