17 results
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20ms
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Sources: EU EUDAMED, US FDA
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310217353·FG Diamond 877-012 beveled cylinder coarse 5/pack
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074034492·BONE SCREW 7021735 10 DEG ILC 7.5X35 SS
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496021735·SOLIDEA LEG, SIZE M, NOISETTE, MICRO-MASSAGING ...
CLEARFIL DC CEMENT
FDA 510(k)
FDA Class 2
·Dental
SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010
MODIFIED KUGEL PATCH
FDA Adverse Event
Malfunction
·DAVOL INC.·Product code FTL·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 26, 2013
WAVELIGHT ALLEGRETTO WAVEZ EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·LIGHT LASER TECHNOLOGIE AG·Product code LZS·March 11, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013
DHF 06 HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code KDI·May 22, 2025
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016
MODIFIED KUGEL PATCH
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·August 2, 2011
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014