16 results · 19ms · Sources: EU EUDAMED, 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