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