144 results
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12ms
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Sources: EU EUDAMED, US FDA
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·November 24, 2014
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.
FDA Recall
Terminated
·Alto Development Corp·Product code LDF·June 21, 2019
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code DDR·November 11, 2015
Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DDR·April 3, 2006
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HTO·July 26, 2017
Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic.
FDA Recall
Terminated
·Dade Behring Inc.·Product code DDR·April 3, 2006
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
FDA Recall
Terminated
·Synthes, Inc.·Product code HWB·March 19, 2018
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
FDA Recall
Terminated
·Pro-Dex Inc·Product code GEY·September 25, 2018
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010
GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010
GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BSZ·August 30, 2010