12 results
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28ms
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Sources: EU EUDAMED, US FDA
TBD ETHICON MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Harvard PremiumFlow Dentine
FDA UDI
Harvard Dental International GmbH·EHAR70822161·Flowable light cure nano-hybrid composite for r...
PMMA disc
FDA UDI
Dentsply International Inc.·D00180822160·
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
FDA 510(k)
FDA Class 1
·General Hospital
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2011
H-TRONPLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 25, 2008
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015