16 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
FDA 510(k)
FDA Unclassified
·Unknown
Silex
FDA UDI
SILEX MEDICAL, LLC·B331EZL103745·Slide Locking Long Stone Cup Dissecting Forceps
SELF CENTERING
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295003588·SELF CENTERING BI-POLAR HEAD 22.225mm ID 45mm OD
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·December 21, 2012
FETAL MONITOR/CARDIOTOCOGRAM
FDA Adverse Event
Injury
·BISTOS CO., LTD.·Product code HGL·January 29, 2018
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 1, 2025
ALLEGRA
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JQC·September 25, 2015
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH LTD./HUNTINGTON·Product code HQL·May 19, 2011
TAPERLOC COMPLETE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 5, 2025
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 2016
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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021