301 results
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10ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories·April 3, 2024
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
FDA Enforcement
Class II
·Ongoing·Cepheid·December 24, 2025
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 10, 2014
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·July 15, 2015
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
FDA Enforcement
Class II
·Terminated·Radiometer America Inc·August 15, 2012
Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·March 22, 2017
Omnipod 5 Automated Insulin Delivery System
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·September 27, 2023
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 4, 2013
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 2, 2016
Universal Battery Charger II (UBC II)
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·June 22, 2016
Philips IntelliSpace Cardiovascular software, Model 830089.
FDA Enforcement
Class II
·Ongoing·Philips Medical Systems Nederland B.V.·March 12, 2025
Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018