66 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·August 20, 2014
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·June 12, 2019
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
FDA Enforcement
Class II
·Terminated·Intelerad Medical Systems·August 27, 2014
Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·October 28, 2020
Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·October 28, 2020
"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping Solution, 1 x 30mL Phosphate Buffered Saline, 1 x 2mL Free Protein S Reagent FOR IN-VITRO DIAGNOSTIC USE LOT: 3-16- 5292 EXP: 2018-01-26 HELENA LABORATORIES BEAUMONT, TX Outer labeling of Substrate (brown bottle and cap): "Substrate 13 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26" Outer Labeling of Protein S Conjugate bottle (clear bottle and cap, red liquid): "Protein S Conjugate 12 mL" FOR IN-VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES Beaumont, Tx "2161421 EXP: 2018-01-26"
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Inc.·October 24, 2018
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
FDA Enforcement
Class II
·Terminated·NEO METRICS, INC.·June 18, 2014
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Enforcement
Class II
·Ongoing·Oto Med Inc·May 12, 2021
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
FDA Enforcement
Class II
·Terminated·Atos Medical AB·May 19, 2021
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·March 31, 2021
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·July 29, 2015
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·January 22, 2014
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
FDA Enforcement
Class II
·Terminated·Helena Laboratories, Inc.·December 12, 2018
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·August 31, 2022
MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
FDA Enforcement
Class II
·Terminated·Snug Seat Inc·December 17, 2014