52 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
FDA Enforcement
Class II
·Terminated·Stryker Craniomaxillofacial Division·February 18, 2015
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
FDA Recall
Terminated
·Stryker Craniomaxillofacial Division·Product code FTL·December 17, 2014
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Acumed LLC·March 22, 2017
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Recall
Terminated
·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code FTM·December 29, 2021
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.
FDA Recall
Terminated
·Acumed LLC·Product code LXH·February 17, 2017
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
FDA Enforcement
Class II
·Terminated·Stryker Leibinger GmbH & Co. KG·March 9, 2022
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code MFC·June 22, 2009
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJK·May 20, 2014
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS Automated urine Chemistry Analyzer and CLINITEK ATLAS 10 reagent Pak, CLINITEK ATLAS Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code JJW·November 21, 2012
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·September 18, 2012
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code JJW·April 20, 2020
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
FDA Recall
Terminated
·Quantimetrix Corporation·Product code JJW·December 21, 2017
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
FDA Recall
Terminated
·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019
AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066
FDA Recall
Terminated
·Product code JOW·August 11, 2010
Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is at risk for deep vein thrombosis or could otherwise benefit from enhanced blood flow and circulation and/or a reduction in post operative pain and swelling.
FDA Recall
Terminated
·Sterilmed Inc·Product code JOW·August 8, 2008
Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.
FDA Recall
Terminated
·Quantimetrix Corporation·Product code JJW·June 1, 2007
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Recall
Terminated
·Thermofisher Scientive·Product code JJW·October 29, 2013
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·July 9, 2012
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
FDA Recall
Terminated
·Compass Health Brands (Corporate Office)·Product code JOW·April 8, 2019