159 results
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8ms
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Sources: EU EUDAMED, US FDA
Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class III
·Ongoing·Datascope Corp.·May 5, 2021
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
FDA Enforcement
Class III
·Ongoing·Datascope Corp.·May 5, 2021
Akreos, SKU: AO60P0300. Akreos intraocular lenses
FDA Enforcement
Class III
·Ongoing·Bausch & Lomb Surgical, Inc.·September 3, 2025
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
FDA Enforcement
Class III
·Ongoing·Abbott Medical·December 4, 2024
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No
FDA Enforcement
Class III
·Ongoing·LUMITHERA INC·July 9, 2025
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
FDA Enforcement
Class III
·Ongoing·Qualigen Inc·January 15, 2025
KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·September 20, 2023
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
FDA Enforcement
Class III
·Ongoing·NuVasive Inc·February 15, 2023
Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
FDA Enforcement
Class III
·Ongoing·AMEDA, INC.·February 21, 2018
GlideScope Go Monitors
FDA Enforcement
Class III
·Ongoing·Verathon, Inc.·August 11, 2021
VenaSeal Closure System
FDA Enforcement
Class III
·Ongoing·Medtronic Inc.·May 19, 2021
Cepheid Xpert C. difficile/Epi Control Panel
FDA Enforcement
Class III
·Ongoing·Microbiologics Inc·June 26, 2019
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
FDA Enforcement
Class III
·Ongoing·Immersivetouch Inc·May 27, 2020
Philips OMNI II TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips OMNI III TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips X7-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips S4-1 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips C9-4 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips L17-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026