12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450204344·
DELTRAN
FDA UDI
UTAH MEDICAL PRODUCTS, INC.·H6719023270·DELTRAN II, Disposable Pressure Transducer Syst...
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
MICRO-TOUCH NITRA FREE
FDA 510(k)
FDA Class 1
·General Hospital
CLEARVISION DR 7000F
FDA 510(k)
FDA Class 2
·Radiology
RESTORE EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·June 30, 2014
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 8, 2013
TEGADERM FILM TRANSPARENT DRESSING FRAME STYLE
FDA Adverse Event
Injury
·3M HEALTH CARE·Product code NAD·November 12, 2010
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 14, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 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