4,063 results · 33ms · Sources: EU EUDAMED, US FDA

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CONDUIT™ ATP Inserters

FDA 510(k)
FDA Class 2 ·Orthopedic

MEGA PLUS SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809665580429·Rod(CoCr), Ø5.5 x 140mm

Introcan Safety ® 2

FDA UDI
B. BRAUN MEDICAL INC.·04046955342051·Introcan Safety 2 - 18G x 1.75 in., PUR, Straight

10M - General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

N/A

FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369443·PEARSON ATTACHMENT- THOMAS LARGE

SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

FDA 510(k)
FDA Class 2 ·Orthopedic

N LATEX IGM

FDA 510(k)
FDA Class 2 ·Immunology

GSB GLOBAL SPINAL BALANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACCU-CHEK ® SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·November 6, 2014

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 1, 2011

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 17, 2013

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·COCHLEAR LTD.·Product code MCM·September 26, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 25, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2014

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·February 28, 2014