20 results
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17ms
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Sources: EU EUDAMED, US FDA
Proclaim DRG Implantable Pulse Generator, Model Number 3664
FDA Enforcement
Class II
·Terminated·St. Jude Medical, Inc.·April 4, 2018
Proclaim DRG Implantable Pulse Generator Model 3664
FDA Enforcement
Class II
·Terminated·St. Jude Medical, Inc.·October 25, 2017
Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
FDA Enforcement
Class II
·Ongoing·Abbott Medical·July 24, 2024
DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·September 4, 2019
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 Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 14, 2019
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
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Enforcement
Class II
·Terminated·DRG International, Inc.·April 13, 2022
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 22, 2018
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA Enforcement
Class II
·Terminated·Topcon Medical Laser Systems, Inc·July 31, 2013
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 18, 2020
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