331 results
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13ms
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Sources: EU EUDAMED, US FDA
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
FDA Recall
Terminated
·Steris Corporation·Product code LRT·August 2, 2012
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·November 29, 2017
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code MBH·November 29, 2017
Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R
FDA Recall
Terminated
·Zimmer, Inc.·Product code JWH·February 25, 2014
Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.
FDA Recall
Terminated
·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·Product code DRT·July 1, 2014
Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·June 16, 2005
Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.
FDA Recall
Terminated
·Datascope Corp·Product code DRT·August 19, 2005
HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).
FDA Recall
Terminated
·HoMedics, Inc.·Product code IRT·February 9, 2007
Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)
FDA Recall
Terminated
·Datascope Corp·Product code DRT·September 7, 2005
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
FDA Recall
Terminated
·Ergoactives, Llc·Product code IRT·January 19, 2016
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
FDA Recall
Terminated
·Datascope Corp·Product code DRT·July 28, 2004
Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016
Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
FDA Recall
Terminated
·2k Innovations Inc.·Product code IRT·April 15, 2016