11 results · 35ms · Sources: EU EUDAMED, US FDA

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STOPCOCK 2-WAY, 3-WAY & 4-WAY

FDA 510(k)
FDA Class 2 ·General Hospital

ULTRAGUIDE CT-GUIDE 1010

FDA 510(k)
FDA Class 2 ·Radiology

CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CUSTOM PAK

FDA Adverse Event
Malfunction ·ALCON - BELGIUM/ ALCON N.V.·Product code KYG·March 24, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 23, 2012

PRECISION XTRA/OPTIUM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 6, 2007

GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

FDA Enforcement
Class II ·Terminated·Zimmer, Inc.·September 10, 2014

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

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