25 results · 15ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

FDA Recall
Open, Classified ·Nihon Kohden America Inc·Product code DRG·January 8, 2021

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code KOO·June 23, 2022

FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code KOO·October 4, 2023

McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.

FDA Recall
Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code DQK·August 21, 2024

Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.

FDA Recall
Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code MWI·August 21, 2024

Horizon Cardiology Hemo. Version 12.2.

FDA Recall
Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code DQK·August 21, 2024

a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986. d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987. e. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY3.5ML PLAS VACUTAINER (100/BX Model Number: 367981. f. BECTON DICKINSON BD Vacutainer TUBE, BLD COL PLAIN RED 10ML GLS VACUTAINER (100/BX 10BX/CS) Model Number: 366430. g. BECTON DICKINSON BD Microtainer SST - Amber TUBE, CAPILLARY CLOT/SEP GLD 400/600UL PLAS MICROT (50/BX) Model Number: 365978. h. BECTON DICKINSON BD Vacutainer CPT NC: 1.0mL FICOLL: 2.0mL TUBE, BLD CPT SOD CIT 8ML (60/CS) Model Number: BD 362761. i. BECTON DICKINSON BD Vacutainer Rapid Serum Tube (RST) Thrombin TUBE, BLD COL CLOT ORG 5ML PETVACUTAINER (100/BX 10BX/CS) Model Number: 368774. j. BECTON DICKINSON BD Vacutainer Buff. Na Citrate 0.109M, 3.2% TUBE, BLD COL SODCIT LTBLU 2.7ML PLAS VACUTAINER (100/BX) Model Number: 363083.

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JKA·May 25, 2022

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

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

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

FDA Recall
Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

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

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

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.

FDA Recall
Open, Classified ·Medtronic, Inc.·Product code KRG·June 17, 2025

BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

FDA Recall
Open, Classified ·Biointellisense Inc. 570 El Camino Real·Product code DRG·July 19, 2024