20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114025·HYDRO-DISSECT FLAT J-SHAPED 27GA (PK/10)
ZGGP ZABLOTSKY GRAFT GUIDING
FDA UDI
W.H. Holden, Inc.·D9282011710·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450156568·
ZGGP ZABLOTSKY GRAFT GUIDING ROUNDED - SHARP
FDA UDI
W.H. Holden, Inc.·D92820117110·
DELTA 16 TACT
FDA 510(k)
FDA Class 2
·Radiology
Q-STRESS ECHO BED
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
HIGH FLOW INSUFFLATION UNIT
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code HIF·May 11, 2022
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011
RELIANT BALLOON
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code DQY·October 27, 2014
SCRDRIVER SHAFT 1.5
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·July 2, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023
2-0 FW LOOP 48" W/MOND NDL 26MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GAT·March 5, 2019
1220246-2019-00931
FDA Adverse Event
Injury
·March 5, 2019
LABRALTAPE, WHITE 1.5MM 36"
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code GAT·March 5, 2019
DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MBI·March 5, 2019
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021