100 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code LTT·May 2, 2013
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
FDA Recall
Terminated
·Orthosensor, Inc.·Product code ONN·July 12, 2018
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JWH·December 1, 2023
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
FDA Recall
Completed
·Avanos Medical, Inc.·Product code GXD·August 1, 2023
CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
FDA Recall
Terminated
·DRG International Inc·Product code JSO·November 9, 2009
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CFP·October 7, 2024
CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.
FDA Recall
Terminated
·DRG International Inc·Product code JSO·November 9, 2009
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 Recall
Open, Classified
·DRG International, Inc.·Product code JLX·September 13, 2024
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Recall
Terminated
·DRG International, Inc.·Product code JKD·December 21, 2021
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Recall
Open, Classified
·DRG International, Inc.·Product code KLI·October 18, 2021
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 Recall
Open, Classified
·DRG International, Inc.·Product code CDZ·July 5, 2024
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Recall
Open, Classified
·DRG International, Inc.·Product code CDX·June 4, 2025
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 Recall
Open, Classified
·American Contract Systems, Inc.·Product code OHD·November 29, 2023
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code PEJ·July 14, 2016
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 Recall
Terminated
·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code CDZ·May 21, 2019