61 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
FDA Enforcement
Class III
·Terminated·Sigma·July 25, 2012
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code JWH·January 18, 2016
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
FDA Recall
Terminated
·Baxter Healthcare Corp·Product code FRN·March 2, 2015
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 24, 2016
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
FDA Recall
Terminated
·Sigma·Product code FRN·April 23, 2012
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corp·April 22, 2015
OEC 9800. MDL Numbers: D222250, D141598
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OWB·December 27, 2016
OEC 9900 Elite. MDL Numbers: D148942, D155043
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OWB·December 27, 2016
OEC 9800. MDL Numbers: D222250, D141598
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·February 1, 2017
OEC 9900 Elite. MDL Numbers: D148942, D155043
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·February 1, 2017
Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
FDA Recall
Terminated
·Western a Scott Fetzer Co·Product code BZD·October 2, 2003
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Recall
Terminated
·Materialise USA LLC·Product code JWH·May 3, 2016
Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04, OrthoPro LLC, Salt Lake City, UT Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty.
FDA Recall
Terminated
·OrthoPro LLC·Product code KWD·May 29, 2008
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·June 15, 2016
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 18, 2017
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·March 25, 2015
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
FDA Enforcement
Class II
·Terminated·Materialise USA LLC·January 15, 2014
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 18, 2017
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
FDA Enforcement
Class II
·Terminated·Materialise N.V.·November 4, 2015
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 18, 2017