13 results
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24ms
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Sources: EU EUDAMED, US FDA
Patient Monitoring Cables
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780421795·Integra® Miltex® Cottle Septum Speculum 5-1/8",...
SILBRONCHO (RIGHT LUNG)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050083935·SILBRONCHO Tube is intended for use in airway m...
SILBRONCHO (RIGHT LUNG)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050123983·SILBRONCHO Tube is intended for use in airway m...
DW 276 #3
FDA 510(k)
FDA Class 2
·Dental
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·October 16, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
PRECISE BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 3, 2013
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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