82 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
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
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 13, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·January 22, 2025
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 21, 2024
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
Pediatric care bed; Product Designation: KayserBett IDA;
FDA Enforcement
Class I
·Ongoing·KAYSERBETTEN GMBH & CO. KG·June 10, 2026
Alinity ci Level Sensor, Bulk Solution
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019
ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020
Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
FDA Enforcement
Class II
·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique.
FDA Enforcement
Class II
·Ongoing·Macherey Nagel Gmbh & Co. Kg·May 22, 2024
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 15, 2024
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·March 15, 2023
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
FDA Enforcement
Class II
·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024