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