16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970546·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970553·
PC ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
ACELL UBM HYDRATED WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
INCLUSIVE MINI IMPLANT O-BALL 3.0 MMD X 10 MML
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 20, 2023
NC QUANTUM APEX?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 21, 2013
ETS FLEX ARTICNG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 14, 2008
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018
INSPIRE HVR DUAL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTN·November 12, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·November 18, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024