16 results · 20ms · Sources: EU EUDAMED, US FDA

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XISCAN 6000 IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·H65810035680·Barbed Broaches Ster Black 6

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964023703·The ENDO CARRY-ON Procedure Kit contains all of...

Alpha-Tec Systems

FDA UDI
Alpha-TEC Systems, Inc.·00816085021645·Auramine O with Potassium Permanganate Stain Set

POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

FDA 510(k)
FDA Class 1 ·General Hospital

HDL CHOLESTEROL PLUS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SALINE-FILL MAMMARY IMPLANT, 240 CC

FDA Adverse Event
MCGHAN MEDICAL CORP.·Product code FWM·October 3, 1994

BREAST IMPLANT, 270 CC

FDA Adverse Event
DOW CORNING CORP.·Product code FTR·October 3, 1994

V500, SAVINA AND VENTILATORS OF EVITA FAMILY

FDA Adverse Event
Other ·DRAGER MEDICAL GMBH·Product code CBK·February 18, 2011

PEDICSCR MATRIX 5.5 POLYAXIAL Ø5.5 PREAS

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code NKB·March 14, 2013

PRECISION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 22, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·February 25, 2008

BD CONVENTIONAL NEEDLES

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·December 3, 2024

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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