25 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CHN OR DAVINCI PROSTATE, Model Number DYNJ902540N
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 26, 2023
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024
microTargeting" Drive System, Product Number MT-DS-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number 66-ZD-MD
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 15, 2020
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
microTargeting" Drive System, Product Number MT-DS
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023
The ICS CHARTR EP 200
FDA Enforcement
Class II
·Terminated·GN Otometrics·October 30, 2019