10 results · 20ms · Sources: EU EUDAMED, US FDA

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DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

Dalbo®

FDA UDI
Cendres+Métaux SA·07640173099710·Dalbo®-S Female part D Spare part

WECK CARDIAC PACING WIRES

FDA 510(k)
FDA Class 2 ·Cardiovascular

MALLORY HEAD MODULAR CALCAR

FDA 510(k)
FDA Class 2 ·Orthopedic

DIMENSION RXL MAX WITH HM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·April 10, 2013

VITALITY

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

DEPUY MITEK ACL INSTRUMENTS

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code HTY·May 19, 2008

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 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

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024