11 results · 28ms · Sources: EU EUDAMED, US FDA

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ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227873·Wullstein House Cup Fcps, jaws cvd left

Rampart One Lumbar Interbody Fusion System

FDA UDI
SPINEOLOGY INC.·M7404902207·Rampart One Oblique Trial, 14mm, M, 8°

MACROPOREPX PEDIATRIC SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

RESTORELLE POLYPROPYLENE MESH

FDA 510(k)
FDA Class 3 ·Obstetrics/Gynecology

ACCU-CHEK ® AVIVA PLUS TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014

DURALOC CONST LINER 54X32

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 15, 2010

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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