19 results
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26ms
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Sources: EU EUDAMED, US FDA
SUCTION CATHETER
FDA 510(k)
FDA Class 1
·Anesthesiology
Trial Tibial Augment
FDA UDI
ADLER ORTHO SPA·08056269044103·TRIAL PANTHEON TIBIAL AUGMENT LM/RL SIZE 3 H5
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78005031·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...
AirLife™
FDA UDI
AIRLIFE·10889483588123·AirLife™ Isothermal Breathing Circuit 1.3 m (4....
pc
FDA UDI
Allied Medical, LLC·00026072016930·FLWMTR,02, MEDSTAR
AirLife™
FDA UDI
AIRLIFE·10190752157408·AirLife™ Isothermal Breathing Circuit 1.3 m (4....
Swivel Side Arm
FDA UDI
KOROS U.S.A., INC.·10840199537102·Swivel Side Arm w/Clamp
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78005031001·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78005030051·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78005030101·Mini Sprint Bracket McLaugh/Benn/Trev. .018" ma...
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MEDART 520 COOLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
FDA Adverse Event
Injury
·VYAIRE MEDICAL·Product code BZE·November 20, 2022
AIRLIFE¿ ISOTHERMAL BREATHING CIRCUIT 1.3 M (4.5') ¿ INFANT RESPIRATORY CIRCUIT
FDA Adverse Event
Malfunction
·VYAIRE MEDICAL·Product code BZE·July 17, 2023
HS III PROXIMAL SEAL SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 11, 2014
TOSHIBA
FDA Adverse Event
TOSHIBA MEDICAL SYSTEMS CORPORATION·Product code IYN·October 22, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 31, 2007
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
FDA Enforcement
Class I
·Terminated·Carefusion 2200 Inc·July 11, 2012
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021