58 results · 18ms · 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.

APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105

FDA Recall
Terminated ·Wilson-Cook Medical Inc·Product code FGE·July 25, 2003

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

FDA Recall
Open, Classified ·Ethicon, Inc. Us·Product code GAM·March 24, 2022

BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code FMI·May 31, 2017

Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

FDA Recall
Open, Classified ·Drs Vascular, Inc·Product code KGS·May 16, 2025

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

Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

FDA Recall
Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 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

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

FDA Recall
Terminated ·DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany·Product code JLS·June 6, 2019

Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code DKB·April 22, 2009

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

Food Allergy Panel Test (IgE)

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DHB·November 3, 2025

Phadia 1000 Instrument, Article Number 12-3800-01.

FDA Recall
Terminated ·Phadia US Inc·Product code DHB·July 5, 2017