17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sungshim Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Liner Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039301·
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 14, 2022
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 14, 2022
TRANS1 AXIALIF PLUS
FDA 510(k)
FDA Class 2
·Orthopedic
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
FDA 510(k)
FDA Class 2
·Dental
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 14, 2022
EVACUATED CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code GCY·January 18, 2022
EVACUATED CONTAINER, 1000 ML
FDA Adverse Event
Malfunction
·BAXTER INTERNATIONAL INC.·Product code GCY·December 27, 2021
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 6, 2019
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
ADVANCE
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code DXE·September 9, 2019
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ELEKTA LIMITED Elekta Synergy, 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