10,000 results
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16ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·October 28, 2020
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GAS·May 3, 2013
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 15, 2012
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Enforcement
Class II
·Terminated·Gsi Group Inc·March 2, 2016
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·May 8, 2013
MultiDiagnost MD4
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
LithoDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 96/97 DSI
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
UroDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
MultiDiagnost MD3
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
EasyDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Easy Diagnost Digital
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
OmniDiagnost
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
Diagnost 76
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009
PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.
FDA Recall
Terminated
·Gsi Group Inc·Product code DSF·December 2, 2015