10 results · 28ms · Sources: EU EUDAMED, US FDA

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SUNSATION

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

VITROS

FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750001224·VITROS Immunodiagnostic Products Anti-HBc Calib...

Oph.Forceps

FDA UDI
KATENA PRODUCTS, INC.·00852979003878·Inamura Capsulorrhexis Cystotome Forceps

THD SLIDE

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO ACCUDEXA BONE DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

PCA ACE/DEEP SOCKET SHELL 55MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·October 17, 2012

PRECISION XTRA/OPTIUM

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE, LTD., UK·Product code NBW·September 25, 2007

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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