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.

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

FDA Recall
Open, Classified ·Turbett Surgical, Inc.·Product code FRG·December 5, 2022

Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

FDA Recall
Open, Classified ·Turbett Surgical, Inc.·Product code FRG·December 5, 2022

Turbett Surgical Container, TS1500

FDA Recall
Open, Classified ·TURBETT SURGICAL, LLC·Product code FRG·April 1, 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

ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

FDA Recall
Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

FDA Recall
Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

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

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

BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.

FDA Recall
Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code FCG·August 2, 2024