14 results · 35ms · Sources: EU EUDAMED, US FDA

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PEDIATRIC AORTIC ROOT CANNULA

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257126691·15-20 MV FOR MEN SELECT EW STD TAN III

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257128756·15-20 MV FOR MEN CLSC EW STD TAN III

BUSCH®, BNA®

FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120401731·Abrasive, green, medium grit

VERTE-STACK ANATOMIC PEEK STRUT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020

CEMENT IT! UNIVERSAL C&B

FDA 510(k)
FDA Class 2 ·Dental

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

PROGRASP FORCEPS INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 19, 2013

BRILLIANCE 64 AIR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·April 3, 2013

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIQ·April 5, 2011

STARCLOSE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·May 8, 2008

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018