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

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ZURICH DISTRACTION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm

PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

FDA 510(k)
FDA Class 2 ·Cardiovascular

MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED

FDA 510(k)
FDA Class 1 ·General Hospital

MINIMED MIO ADVANCE

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·May 20, 2025

ONE TOUCH PING METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·June 3, 2010

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·March 19, 2013

MP50 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·February 11, 2011

NA

FDA Adverse Event
Other ·B. BRAUN MEDICAL INC·Product code FMI·March 10, 2008

COBAS C111

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·March 3, 2010

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

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