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