20 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FuseForce Flex Dynamic Compression System
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable Iris Retract
FDA UDI
KATENA PRODUCTS, INC.·00841668114346·FLEXIBLE IRIS RETRACTORS 5 PKS of 5
UltraStick - HJ & Associates PL
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237900949·2"x 3.5" Cloth
UltraStick
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850689007589·2"x 3.5" Cloth, Case of 10
UltraStick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850689007582·2"x 3.5" Cloth
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 17, 2018
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 17, 2018
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 2, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
CAPSURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 3, 2013
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
HOSP SS FLEXX METER LASER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 17, 2011
HOSP SS FLEXX METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 12, 2011
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 26, 2024
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