16 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112960·CORNEAL TREPHINE BLADE8.75MM
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
S2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
FDA 510(k)
FDA Class 2
·Dental
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·August 5, 2011
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NTE·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·October 19, 2022
THERASPHERE Y-90 (5 GBQ) CE MARK
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·February 5, 2025
MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD
FDA Adverse Event
Malfunction
·MOTIVE HEALTH, INC.·Product code IPF·March 7, 2024
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023