29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Flume Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Barrier
FDA UDI
Mölnlycke Health Care AB·07323190000654·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128960·Femoral Augment, Notched Posterior, Size 1, 10mm
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690196754·NOTCHED POSTERIOR AUGMENT TRIAL REVISION FEMUR ...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946061975·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LE...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946030360·X SERIES ADVANCED, 12 LEAD W/INTERP, PACE, SPO2...
Life Instruments
FDA UDI
Life Instrument Corporation·M930723110100·Jack Elevator 11"
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ITERO SOFTWARE
FDA 510(k)
FDA Class 2
·Dental
EXEL HYPO NDL 27GX1-1/2"
FDA Adverse Event
Injury
·EXELINT INTERNATIONAL, CO.·Product code FMF·March 28, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·June 18, 2025
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·May 28, 2024
OMNI-FLOW MODEL 4000 PLUS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 30, 2008
ENTERRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LNQ·August 26, 2011
PLUM XLM W/ DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013
BD PHOENIX NMIC-311
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·April 14, 2021
BD CONVENTIONAL NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 26, 2024
EXEL HYPO NDL 27GX1-1/2
FDA Adverse Event
Injury
·EXELINT INTERNATIONAL, CO.·Product code FMF·June 7, 2025
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
FDA Enforcement
Class II
·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025