16 results · 21ms · Sources: EU EUDAMED, US FDA

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Navagio

FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm

SYNTHES ANKLE ARTHRODESIS PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033487501·

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm

ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ISODAN

FDA 510(k)
FDA Class 2 ·Dental

DIDECO LILIPUT ECMO M PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012

MATRIXMANDIBLE SHORT CUT PLATE CUTTER

FDA Adverse Event
Malfunction ·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code HTZ·January 15, 2018

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 20, 2013

CESAR-OMCP-VISUB (HM3000)

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code IZF·February 2, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.

FDA Enforcement
Class II ·Terminated·Greatbatch Medical·June 8, 2016

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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014