16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANSVAGINAL ENDOSCOPY SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033728·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828106405·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828142298·GEN4 Direct Access
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828142069·GEN4 Direct Access
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRACH VOX
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 10, 2025
SQ-RX PULSE GENERATOR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWS·February 4, 2025
THE Q-TRAK SUBCUTANEOUS ELECTRODE
FDA Adverse Event
Injury
·OSCOR INC·Product code LWS·February 4, 2025
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 3, 2013
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·March 23, 2011
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FDA Adverse Event
Malfunction
·TORNIER·Product code HSD·April 9, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024