21 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
FDA 510(k)
FDA Class 2
·Anesthesiology
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964010192·Endo Carry-On Procedure Kit
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001121·artVeneer life lower anteriors, UCS, A35
Silicone Tubing
FDA UDI
INVOTEC INTERNATIONAL, INC.·00818501022724·Silicone Tubing
NA
FDA UDI
Berchtold Holding GmbH·07613327170191·Elongation bar for anesthesia screen. Keep Dry.
BD PHASEAL PROTECTOR P50
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 29, 2020
TITAN XL
FDA Adverse Event
Injury
·CUTERA·Product code GEX·June 14, 2010
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
FDA 510(k)
FDA Class 2
·Cardiovascular
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
FDA 510(k)
FDA Class 2
·Immunology
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
iBOT PMD with software version 01.05.24. Personal Mobility Device.
FDA Enforcement
Class II
·Ongoing·Mobius Mobility LLC·June 18, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013
DESARA
FDA Adverse Event
Other
·CALDERA MEDICAL·Product code FTL·February 17, 2011
TUBE, GASTROINTESTINAL (AND ACCESS)
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code KNT·February 15, 2008
BD PHASEAL INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·June 29, 2020
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006
PDS CORD UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·December 12, 2017
INTACS CORNEAL IMPLANTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025