12 results
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7ms
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Sources: EU EUDAMED, US FDA
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
FDA Enforcement
Class II
·Ongoing·Medline Industries, LP·February 4, 2026
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·January 22, 2025
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·February 7, 2024
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No
FDA Enforcement
Class II
·Ongoing·Drs Vascular, Inc·August 27, 2025
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Enforcement
Class II
·Ongoing·DRE Medical Group Inc·July 5, 2023
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·February 7, 2024