17 results · 24ms · Sources: EU EUDAMED, 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