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