15 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DELSONIC 2000
FDA 510(k)
FDA Class 2
·Dental
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450819739·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142080·Trial, TLIF, 32L OB CRV 7Deg, 8mm
Phonak
FDA UDI
Phonak AG·07613275097687·Phonak Audéo Q70-10 (purple transparent)
COAPTITE
FDA Adverse Event
Other
·MERZ AESTHETICS INC·Product code LNM·November 4, 2011
ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+
FDA 510(k)
FDA Class 2
·General Hospital
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
0009613348-2024-014238
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·October 23, 2024
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 6, 2013
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·August 18, 2014
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2011
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·September 3, 2010
ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·January 2, 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
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014