19 results · 28ms · Sources: EU EUDAMED, US FDA

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DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bioseal Inc.

FDA UDI
BIOSEAL·00630094199016·Adult Bite Block

PROCARE

FDA UDI
DJO, LLC·00888912037259·FOAM LIMB RESTRAINT,PR,UNIV

B.BRAUN

FDA UDI
B. BRAUN MEDICAL INC.·04046964187773·Evacuated IV Container, Glass, 500 mL

General

FDA UDI
Seaspine Orthopedics Corporation·10889981143275·Graft Delivery Instrument Tray Case - Base

EARGO

FDA UDI
Eargo, Inc.·00850010429168·EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm...

NanoBone SBX PUTTY, NanoBone QD

FDA 510(k)
FDA Class 2 ·Orthopedic

PREPARATION, DUPONT

FDA 510(k)

PREMIER ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

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

PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·March 5, 2013

SIGMA 200 DR

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·February 15, 2011

VIRTUOSO

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 7, 2014

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016