13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELI 350 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
HARDYDISK NETILMICIN, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 17, 2026
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
TIP COVER ACCESSORY
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013
LUMAX 340 VR-T
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code LWS·August 1, 2008
EON C 16-CHANNEL IPG
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011
TFNA FEM NAIL Ø11 LE 130° L300 TIMO15
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·January 9, 2017
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
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024