12 results
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26ms
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Sources: EU EUDAMED, US FDA
EASY LIFE
FDA 510(k)
FDA Class 2
·Physical Medicine
Safco CleanCare Pro Prophy Paste
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310235213·Safco CleanCare prophy paste, medium bubblegum,...
ZESPIN SI Joint Fusion System
FDA UDI
Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm
DISPO-MED 7.6 LITER SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
GEMINI IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MCLAUGHLIN +5 ACET 54MMX24L
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWZ·March 27, 2013
8800
FDA Adverse Event
Malfunction
·GE MED SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·March 1, 2011
AXIALIF SYSTEM
FDA Adverse Event
Other
·TRANS1 INC.·Product code JDN·March 28, 2008
COMP VRSDL GLNSPR 36MM TI
FDA Adverse Event
Injury
·Product code KWS·August 10, 2021
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 Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018