159 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 14, 2015
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 Enforcement
Class II
·Terminated·Alto Development Corp·August 7, 2019
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma Catalog Number: CMYO SMN:10445079
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 20, 2014
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·August 27, 2014
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
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·October 31, 2012
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