10 results
·
12ms
·
Sources: EU EUDAMED, US FDA
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
dS Breast 16ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
FDA Enforcement
Class II
·Terminated·Medtronic·March 22, 2017
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11 (6)S913BX 5-0 NYLON 10 DS12 (7)S931BX 4-0 NYLON 10 DS12
FDA Enforcement
Class II
·Ongoing·Covidien, LP·March 8, 2023
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Enforcement
Class II
·Ongoing·Withings·March 29, 2023