132 results · 12ms · Sources: EU EUDAMED, US FDA

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Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662

FDA Recall
Terminated ·Ebi, Llc·Product code LXH·August 13, 2013

HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

FDA Recall
Terminated ·HemoCue AB Kuvettgaten 1 Angelholm Sweden·Product code GKR·July 25, 2013

BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,

FDA Recall
Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code MLA·June 13, 2013

PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

FDA Recall
Terminated ·SpineFrontier, Inc.·Product code HXB·September 11, 2013

RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.

FDA Recall
Terminated ·Instrumentation Industries Inc·Product code CAI·November 13, 2013

Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

FDA Recall
Terminated ·Synergetics Inc·Product code HQB·December 9, 2013