22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTA LITE CELIAC DGP SCREEN
FDA 510(k)
FDA Class 2
·Immunology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000840·2.7mm x 8mm Safety Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694062909·2.4 System x 8mm Emergency Screw Sterile Qty 2
KAVO CORUND HANDPIECE 2013
FDA 510(k)
FDA Class 2
·Dental
ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
TAPE HY-TAPE 1"X5YD
FDA Adverse Event
Malfunction
·HY-TAPE INTERNATIONAL, INC.·Product code KGX·January 8, 2024
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·April 17, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 19, 2011
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·June 16, 2008
SYRINGE 10ML LL EUROGRAPHICS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 27, 2021
2.4MM X 8MM SCREW
FDA Adverse Event
Injury
·OSTEOMED, LLC·Product code DZL·July 12, 2023
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 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