53 results · 12ms · Sources: EU EUDAMED, US FDA

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Diode Laser Hair Removal model: WLA-01

FDA Recall
Open, Classified ·WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China·Product code GEX·August 23, 2024

Non-ablative Fractional Laser Systems, Model: WFB-01

FDA Recall
Open, Classified ·WINGDERM ELECTRO-OPTICS LTD. Room 312 Building D-3, Dongsheng Science Park, No.66 Of Xixiaokou Road, Haidian District Beijing China·Product code ONG·August 23, 2024

STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

FDA Recall
Open, Classified ·Product code JIN·October 2, 2023

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

FDA Recall
Open, Classified ·Medline Industries Inc·Product code JIN·March 15, 2021

microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

FDA Recall
Open, Classified ·FHC, Inc.·Product code HAW·October 4, 2024

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

FDA Recall
Open, Classified ·IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands·Product code FQO·March 27, 2025

Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

FDA Recall
Open, Classified ·IHB OPERATIONS B.V. Floresstraat 52 Zwolle Netherlands·Product code FQO·July 19, 2023

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

Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.

FDA Recall
Open, Classified ·Steris Corporation·Product code FEB·June 13, 2024

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FEB·March 25, 2026

Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code FEB·May 26, 2023

Food Sensitivity Test Large

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

Olympus OER-Pro

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025

Olympus OER-Mini

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025

Pet Allergy Test

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

Olympus OER-Elite

FDA Recall
Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FEB·October 31, 2025