21 results · 23ms · Sources: EU EUDAMED, US FDA

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RANGE SPINAL SYSTEM (MESA AND DENALI)

FDA 510(k)
FDA Class 2 ·Orthopedic

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...

BioCare Safety Needles

FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

Fuji

FDA UDI
LANCER ORTHODONTICS, INC.·00817573024445·FUJI ORTHO-SELF CURE CEMENT STARTER

UCR

FDA UDI
Seaspine Orthopedics Corporation·10889981063238·CROSSBAR, XSMALL, 5.5 ROD

ACHIEVE MAPPING CATHETER

FDA Adverse Event
Injury ·MEDTRONIC MEXICO·Product code DRF·July 19, 2016

AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

FDA 510(k)
FDA Class 2 ·Anesthesiology

CASPIAN Spinal System

FDA UDI
VB Spine LLC·10888857242180·Mini Axial AO Handle, Ratchet

PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code KWI·January 25, 2017

PALAXPRESS, CLEAR, 1000G POWDER

FDA Adverse Event
Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·May 2, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 8, 2022

8MM TI STRAIGHT RADIAL STEM 28MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

22MM COCR RADIAL HEAD STANDARD HEIGHT/12.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·January 24, 2017

18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

7MM TI STRAIGHT RADIAL STEM 26MM-STERILE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code KWI·September 7, 2017

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014