109 results
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34ms
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Sources: EU EUDAMED, US FDA
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
FDA Enforcement
Class II
·Terminated·CareFusion Corporation·April 3, 2013
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
FDA Recall
Terminated
·CareFusion Corporation·Product code BRY·November 20, 2009
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·October 6, 2021
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FZP·April 16, 2021
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·October 6, 2021
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code FPA·September 7, 2018
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·November 6, 2019
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MHX·December 17, 2010
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MHX·May 3, 2011
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·October 17, 2018
Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product size configuration: Set of 4 bottles including Schiff Reagent 225mL, Light Green SF Yellowish Stain 225mL, Sodium Carbonate Solution 225mL, and Periodic Acid Solution 225mL. Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code KKS·July 25, 2006
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V. Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
FDA Enforcement
Class II
·Terminated·Vitrolife Inc·April 22, 2015
Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.
FDA Recall
Terminated
·EMD Chemicals Inc·Product code HZT·June 2, 2008
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019
BD Microtainer SST Part/Catalog No.365967
FDA Recall
Terminated
·Becton Dickinson & Company·Product code JKA·May 13, 2019