21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QMS AMIKACIN REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490484749·MESH 9052815 PYRAMESH IMP 22MMX28MMX15MM
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000855871·MESH 9052815 PYRAMESH IMP 22MMX28MMX15MM
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391408·Rib Screw, Ø2.8 x 15mm, Qty. 3
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391415·Rib Screw, Ø2.8 x 15mm, Qty. 8
Valkyrie Rib Thoracic Fixation System
FDA UDI
J.M. Longyear Manufacturing, LLC·00810071391392·Rib Screw, Ø2.8 x 15mm, Qty. 1
GOLD CORE HF PRE SOLDER
FDA 510(k)
FDA Class 2
·Dental
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
FDA 510(k)
FDA Class 1
·General Hospital
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·August 22, 2024
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·May 27, 2008
ASR ACETABULAR CUPS 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011
BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 6, 2024
BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·February 11, 2025
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·April 24, 2019
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010