67 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016
Pressure Monitoring Set, C-PMS, G02838
FDA Recall
Terminated
·Cook Inc.·Product code DQY·April 30, 2020
Pressure Monitoring Set, C-PMS, G02838
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 10, 2020
The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 27, 2007
Femoral Artery Pressure Monitoring Set
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 21, 2018
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
FDA Recall
Terminated
·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
FDA Recall
Terminated
·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021
STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·February 25, 2008
STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·February 25, 2008
STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·February 25, 2008
STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·February 25, 2008
STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·February 25, 2008
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
FDA Enforcement
Class II
·Terminated·Custom Assemblies Inc·August 30, 2017
740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008
AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.
FDA Recall
Terminated
·American Medical Systems·Product code JCW·February 9, 2007
AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders.
FDA Recall
Terminated
·American Medical Systems·Product code JCW·February 9, 2007
The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
FDA Enforcement
Class II
·Terminated·PMBS, LLC·April 6, 2016