22 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMF RESORBABLE MESHES AND SHEETS
FDA 510(k)
FDA Class 2
·Dental
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496003786·NAOMI 70, SIZE XL, CHAMPAGNE, GRADUATED COMPRE...
SCANLAN® Titanium Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159003758·S LEGACY Mic fcp, RH NS DG, 1x2 t, str 1.0 mm D...
BIOSENSORS CENTRAL VENOUS CATHETER KITS
FDA 510(k)
FDA Class 2
·General Hospital
TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
FDA 510(k)
FDA Class 2
·Dental
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009
SURGITEK MAMMARY IMPLANT, 300 CC
FDA Adverse Event
MEDICAL ENGINEERING CORP.·Product code FTR·October 24, 1994
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWS·March 12, 2013
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·February 7, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 12, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·July 26, 2011
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
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