16 results
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20ms
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Sources: EU EUDAMED, US FDA
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