12 results · 29ms · Sources: EU EUDAMED, US FDA

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APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER

FDA 510(k)
FDA Class 2 ·Orthopedic

Ormco

FDA UDI
ORMCO CORPORATION·00889989053104·LIT-TORQ TWIN 018X025 W/HK LEFT

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122193·KWire .035x9" (0.9x225mm)

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450309070·

MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

HEARTTRENDS

FDA 510(k)
FDA Class 2 ·Cardiovascular

DIDECO COMPACTFLO EVOLUTION OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 15, 2016

EVOLUT PRO PLUS VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 21, 2025

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·May 3, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

ACCURUS 800CS

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 5, 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