492 results · 17ms · 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.

i-STAT EG6+ cartridge; List Number: 03P77-25;

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

i-STAT G3+ cartridge; List Number: 03P78-26;

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

i-STAT EG7+ cartridge; List Number: 03P76-25;

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·April 1, 2026

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

FDA Recall
Open, Classified ·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code LCO·December 15, 2025

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

FDA Recall
Open, Classified ·Aniara Diagnostica LLC·Product code LCO·April 1, 2026

SIMPLY SALINE NASAL MIST 3.1 OZ, SKU 999801

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

GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

FDA Recall
Open, Classified ·GAGA PRO LIGHTING EQUIPMENT CO.·Product code REA·September 23, 2022

KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GET·February 14, 2023

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code MOQ·September 23, 2024

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

FDA Recall
Open, Classified ·Pro-Dex Inc·Product code GEY·February 15, 2023

HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

FDA Recall
Open, Classified ·Hamilton Co·Product code JQW·January 15, 2021

WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporates use of the firm's cleared EEG analysis technology (the WAVi SCAN EEG System and Accessories, and the WAVi Headset and eSoc Single Use Electrode Contacts).

FDA Recall
Open, Classified ·WAVi Co.·Product code GWQ·December 8, 2023

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTY·November 21, 2022

BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231632and 231633

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

BD BBL Sensi Disc Aztreonam - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640and 231641.

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

BD BBL Sensi Disc Augmentin - 3g, Catalog Number 291270used for semi-quantitative in vitro susceptibility testing.

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermentation, oxidation, degradation, and hydrolysis in combination with chromogenic and fluorogenic substrates along with carbon sources for yeast identification.

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code LON·February 29, 2024

BD COR System Software. Model Number: 444829.

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code MAQ·June 23, 2025

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

FDA Recall
Open, Classified ·Becton Dickinson & Co.·Product code KZJ·April 7, 2026