21 results · 21ms · Sources: EU EUDAMED, US FDA

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TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)

FDA 510(k)
FDA Unclassified ·Unknown

Full Wedge Lateralized and Augmented Baseplates

FDA UDI
FX SOLUTIONS·03701037319079·HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEP...

DIXI 2

FDA 510(k)
FDA Class 2 ·Dental

ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

SIEMENS : ARTISTE MV

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010

NAVLOCK UNIVERSAL GREEN TRACKER

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015

SCREW DRIVER

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019

PLUM A+ DRIVER ED 2

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 8, 2013

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 5, 2011

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

CART 9734056 S7 STAFF SHRT 100-120V INTL

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018

NAV THORACIC PROBE TIP

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014

IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

NEUROLOGICAL STEREOTAXIC INSTRUMENT

FDA Adverse Event
Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015

CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.

FDA Recall
Terminated ·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011

CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

FDA Recall
Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010

Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

FDA Enforcement
Class II ·Terminated·Ondamed Inc·May 16, 2018