12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HYPER SAL
FDA 510(k)
FDA Class 2
·Anesthesiology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070498·BE YOU TONIC PRO, SIZE ML, RIBES, GRADUATED COM...
Dalbo®-Rotex
FDA UDI
Cendres+Métaux SA·07640166514800·Dalbo®-Rotex
by Dr. Dalla Bona
Spanner key for ...
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WRISTWATCH BLOOD PRESSURE MONITOR A46
FDA 510(k)
FDA Class 2
·Cardiovascular
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 22, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·March 29, 2011
ACCU-CHCK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 7, 2008
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
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