74 results
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13ms
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Sources: EU EUDAMED, US FDA
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTT·May 2, 2013
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
FDA Recall
Terminated
·DRG International Inc·Product code JSO·November 9, 2009
CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
FDA Recall
Terminated
·DRG International Inc·Product code JSO·November 9, 2009
life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.
FDA Recall
Terminated
·Exocomm Tech Grp·Product code MKJ·September 3, 2007
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Recall
Terminated
·DRG International, Inc.·Product code JKD·December 21, 2021
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code PEJ·July 14, 2016
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
FDA Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
FDA Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code JLS·June 6, 2019
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code FRG·March 6, 2013
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
FDA Recall
Terminated
·Boston Scientific Corporation·Product code DRG·May 15, 2017
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
FDA Recall
Terminated
·Steris Corporation·Product code FRG·December 2, 2020
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
FDA Recall
Terminated
·Steris Corporation·Product code FRG·December 2, 2020
-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300. -Ligaclip MCA Multiple Clip Applier, 20 Small Clips Small. REF MCS20 Lot 122300. - Ethicon Pistol Grip, Fixed Head Skin Stapler, Multi-Directional Release, (Grey) 35W. REF PXW35 Lot 122309 and Lot 123263. -Proximate Linear Cutter, w/o Staples 75mm. REF TLC75 Lot 122490 -Ethicon Proximate Plus MD, Skin Stapler Regular. REF PMR35 Lot 122753. -Proximate Plus, Rotating Head, Skin Stapler (White) Wide. REF PRW35 Lot 122406. - Ethicon PROXIMATE PLUS, Skin Stapler, Pistol Grip, Fixed Head, Multi-Directional Release, (Grey) Regular. REF PXR35 Lot 122675 and Lot 123263. -TX Reloadable Linear Stapler 3.5mm Leg, w/o Staples 60mm. Ref. TX60B Lot 122490 Manual surgical instrument for general use
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code GAG·May 3, 2013
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.
FDA Recall
Terminated
·Steris Corporation·Product code FRG·June 15, 2017