13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAXAIR SURGICAL HELMET SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503041·Open CT-Indicator - Left Plate
Mini Master Series Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746070822·1 PAT SETUP MINI MS ROTH 022 U/L 5X5 W/HK 3 STI...
HYDRO2, HS-75
FDA 510(k)
FDA Class 2
·Ophthalmic
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
STELO GLUCOSE BIOSENSOR SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code SAF·February 19, 2025
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
ACRSYOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD.·Product code HQL·May 9, 2008
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024