20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HNC-63-INT NEUROVASCULAR ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
Roticulator 55 Poly
FDA UDI
Covidien LP·10884521047648·Stapler with Polysorb Staples
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544150·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544129·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544136·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544174·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544143·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544167·
UNBRANDED
FDA UDI
FGX INTERNATIONAL INC.·00193033544181·
D3 Ultra
FDA UDI
DIAGNOSTIC HYBRIDS, INC.·30014613330462·Parainfluenza 2 DFA Reagent
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VECTORVISION HIP
FDA 510(k)
FDA Class 2
·Neurology
TM ANKLE XL POLY INSERTS
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·May 25, 2018
RESUS BAG AD MANUAL VARIABLE 6/CS
FDA Adverse Event
CAREFUSION·Product code BTM·March 20, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 10, 2011
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GAG·March 14, 2008
TM ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·March 7, 2018
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014