18 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SunMed
FDA UDI
SUNMED, LLC·10889483008881·GreenLine SunBrite LED PENLITE HANDLE
IDENT-A100 INTRAORAL VIDEO CAMERA
FDA 510(k)
FDA Class 1
·Dental
HARDYDISK SULFISOXAZOLE
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 28, 2025
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 29, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 29, 2013
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 10, 2013
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 27, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·February 18, 2011
1.1 DISPOSABLE GOMCO
FDA Adverse Event
NELLCOR·Product code FHG·March 26, 2008
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 11, 2014
SUNMED
FDA Adverse Event
Malfunction
·SUNMED HOLDINGS LLC·Product code CCW·September 11, 2024
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·March 28, 2024
GREENLINE
FDA Adverse Event
Malfunction
·MEDICAL DEVICES·Product code CCW·January 3, 2019
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018