17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Aduro Light Beauty Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113271·STAB KNIFE 15 DEGREE (BX/5)
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707184186·Accufit Molar Bands Lower Left Second Molar 39
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
FDA 510(k)
FDA Class 2
·Physical Medicine
HITACHI ALTAIRE
FDA 510(k)
FDA Class 2
·Radiology
BD ANGIOCATH PLUS¿ I.V. CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·September 8, 2022
SYNERGY XD DRUG ELUTING STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code NIQ·July 26, 2023
HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·September 15, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
THERASPHERE Y-90 GLASS MICROSPHERES
FDA Adverse Event
Death
·BIOCOMPATIBLES UK LIMITED·Product code NAW·August 30, 2023
UNK_SMART TOUCH BIDIRECTIONAL
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·March 18, 2023
RHA 3
FDA Adverse Event
Injury
·TEOXANE SA·Product code LMH·May 3, 2023
RADIESSE
FDA Adverse Event
Injury
·MERZ NORTH AMERICA, INC (FRANKSVILLE)·Product code LMH·March 6, 2025
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