156 results
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6ms
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Sources: EU EUDAMED, US FDA
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
Philips Mini Multi TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips 3D6-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips S5-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips X3-1 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips L12-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026