12 results
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19ms
·
Sources: EU EUDAMED, US FDA
Suntanning Lamps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoMed
FDA UDI
OSTEOMED LLC·00842528127674·2.4 X 36mm Cannulated Headless Screw, T7
Sklar®
FDA UDI
SKLAR CORPORATION·10649111307645·LEXER SCISS CVD 6 1/4
PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
FDA 510(k)
FDA Class 2
·Cardiovascular
NOBEL ACTIVE 3.0
FDA 510(k)
FDA Class 2
·Dental
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 3, 2014
RELIA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013
XPOSE 4 DEVICE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code DXC·June 24, 2011
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
SCREWDRIVER BIT T15, AO FITTING
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code HWC·October 6, 2017
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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