16 results
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37ms
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Sources: EU EUDAMED, US FDA
MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120202491·Carbide - Excavating and fissure burs
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717102434·Midway Select Imp Mat'l Heavy Reg Set
Illusion™ Univeral Restorative
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310202493·Safco universal restorative A3 syr
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036019679·
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016
TROJAN PLEASURE PACK LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 25, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Other
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 10, 2011
VITROS 350 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 26, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·H10·Product code KWP·April 4, 2013
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018