73 results · 13ms · 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.

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 6, 2025

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

FDA Recall
Open, Classified ·Howmedica Osteonics Corp.·Product code HAW·November 12, 2025

Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

FDA Recall
Open, Classified ·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025

Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and Proximal Tibia in adult patients, in emergent situations. Component: N/A

FDA Recall
Open, Classified ·Waismed Ltd. 11, Galgalei Ha-Plada Pob 12135 Herzliya Israel·Product code FMI·June 5, 2025

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code BXN·May 17, 2024

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036

FDA Recall
Open, Classified ·B. Braun Medical, Inc.·Product code FPA·August 8, 2024

SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FJK·August 15, 2024

Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.

FDA Recall
Open, Classified ·Parker Laboratories, Inc.·Product code GYB·March 22, 2024

natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

FDA Recall
Open, Classified ·Natus Neurology Inc·Product code GYB·February 7, 2024

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490

FDA Recall
Open, Classified ·Cook Incorporated·Product code DYB·March 1, 2024

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

FDA Recall
Open, Classified ·St. Jude Medical·Product code DYB·April 30, 2024