15 results · 22ms · Sources: EU EUDAMED, US FDA

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NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204

FDA 510(k)
FDA Class 2 ·Neurology

Hern Dilator

FDA UDI
MEDGYN PRODUCTS, INC.·M803030827·Hern Dilator 101Fr (33.6 mm)

Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

FDA UDI
TENON MEDICAL, INC.·B74240308270·10mm Drill Spacer 10mm

PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION

FDA 510(k)
FDA Class 2 ·General Hospital

UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

FDA 510(k)
FDA Class 2 ·Orthopedic

ZEPHIR® ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014

VANGUARD PFR FEMORAL LT SM

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·March 27, 2013

TERUMO CDI 500 BLOOD PARAMETER MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 4, 2011

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE LTD·Product code FRN·April 17, 2008

ZEPHIR ANTERIOR CERVICAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 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