14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Classic
FDA 510(k)
FDA Class 2
·Dental
J6 ARM FOR HIP WITH QD
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 15, 2016
J6 ARM FOR HIP WITH QD
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 28, 2015
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996133395·LATERAL,CONVEX EP SCRAPER,TIP,15DEG
PERMOBIL M300 / M400
FDA 510(k)
FDA Class 2
·Physical Medicine
BIOLOY
FDA 510(k)
FDA Class 2
·Dental
RSP INSTRUMENTATION
FDA Adverse Event
Malfunction
·ENCORE MEDICAL, L.P.·Product code HWA·October 17, 2008
ADVISA DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·August 11, 2011
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·December 23, 2022
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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