13 results · 29ms · Sources: EU EUDAMED, US FDA

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ORTHOPEDIATRICS BONE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

K082959

FDA UDI
Unimed Medical Supplies, Inc.·06945664812412·SpO2 interface cable/Philips-Masimo/2.2M/309+12...

Unimed

FDA UDI
Unimed Medical Supplies, Inc.·06936735463947·One-piece ECG Monitor Cable Philips

URETEX SUP PUBOURETHRAL SLING

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

MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD LUER-LOK TIP SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 19, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

SIGN IM NAIL

FDA Adverse Event
Injury ·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·April 23, 2013

NEXGEN LPS ARTICULAR SURFACE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·May 3, 2011

CALAXO - UNKNOWN

FDA Adverse Event
Other ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code HWC·July 25, 2008

1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code DZI·May 19, 2015

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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