9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
FDA 510(k)
FDA Class 2
·Orthopedic
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
ENSITE 3000 SYSTEM, MODEL EE3000
FDA 510(k)
FDA Class 2
·Cardiovascular
EXPRO ELITE SNARE
FDA Adverse Event
Injury
·VASCULAR SOLUTIONS, INC·Product code MMX·June 19, 2017
ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 22, 2013
QUICKSITE LV
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code OJX·January 14, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
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,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024