10 results · 19ms · Sources: EU EUDAMED, US FDA

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REVERTO 55 AND 37 SHAPE MEMORY STAPLES

FDA 510(k)
FDA Class 2 ·Orthopedic

PRECLUDE MVP DURA SUBSTITUTE

FDA 510(k)
FDA Class 2 ·Neurology

AURELUX Y 84 PREMIUM

FDA 510(k)
FDA Class 2 ·Dental

EXPRO ELITE SNARE

FDA Adverse Event
Injury ·VASCULAR SOLUTIONS, INC·Product code MMX·June 19, 2017

PROXIMATE ILS CURVED CIR STAPL

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 22, 2013

TOTAL ASR FEM IMP SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·July 2, 2008

Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015