14 results
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20ms
·
Sources: EU EUDAMED, US FDA
ORTHOPANTOMOGRAPH OP 3D
FDA 510(k)
FDA Class 2
·Radiology
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMISTEM-H HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 29, 2017
UNISYN HIP SYSTEM
FDA Adverse Event
Injury
·CONSENSUS ORTHOPEDICS, INC.·Product code LPH·August 26, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 23, 2013
TOTALCARE-
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 22, 2011
PLUM A+ PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·September 15, 2008
MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
FDA Adverse Event
Malfunction
·MENTOR TEXAS·Product code LCJ·October 20, 2020
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 24, 2022
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·June 27, 2024
MENTOR CPX 4 BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·December 9, 2022
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018