12 results · 22ms · Sources: EU EUDAMED, 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