26 results · 21ms · Sources: EU EUDAMED, US FDA

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SUMO ACCESS AND TISSUE RESECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58211031550·

NexxZr™ / W-98-10-UT-D300-ML

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139733·

UNI-ELBOW

FDA UDI
Stryker GmbH·00886385026114·Radio Capitellum, Trial, Left SM

AXEL WIRE TWISTER/CUTTER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051799·AXEL WIRE TWISTER/CUTTER WITH HOLE NEEDLE HOLDE...

Orthopaedic Surgical Instruments

FDA UDI
CITIEFFE SRL·08056711921396·

DADE THROMBOPLASTIN C PLUS

FDA 510(k)
FDA Class 2 ·Hematology

VERTEBRAL BODY REPLACEMENT

FDA 510(k)
FDA Class 2 ·Orthopedic

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

TAXUS® LIBERTÉ®

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 9, 2013

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 19, 2014

TECNIS

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·May 25, 2011

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

TAPERLOC COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025

Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

FDA Enforcement
Class II ·Terminated·Cardio Medical Products·July 17, 2013

Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management

FDA Enforcement
Class I ·Terminated·Teleflex Medical·June 26, 2019

Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012