9 results · 20ms · Sources: EU EUDAMED, US FDA

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BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML

FDA 510(k)
FDA Class 2 ·Microbiology

MODIFICATION TO SYNTHES (USA) POLYPIN

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM

FDA 510(k)
FDA Class 1 ·Orthopedic

COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

FDA Adverse Event
Malfunction ·ETHICON, INC·Product code GAM·March 27, 2013

NEXGEN LEGACY LCCK ARTICULAR SURFACE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·March 16, 2011

GUIDANT VASO VIEW HEMOPRO

FDA Adverse Event
Malfunction ·GUIDANT CARDIAC SURGERY·Product code GEI·April 2, 2008

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