15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099938·R&L MAX MOLAR 214 BDS W/O LUGS
iTotal STEM DRILL 12MM W/ HUDSON ADAPTOR
FDA UDI
Conformis, Inc.·00810933030230·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756140102·Foley Temp Catheter w/ Urine Meter
BONASTENT® Biliary
FDA UDI
Sewoon Medical Co., Ltd.·08806369461146·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306811388·Olsen-Hegar Needle Holder, Serrated Jaws, 18cm
SYNTHES ANTEROLATERAL CALCANEAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MACROPRO GEL
FDA 510(k)
FDA Unclassified
·Unknown
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 24, 2024
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
POPULAR PLASTICS·Product code IKX·April 26, 2013
METRX
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK MFG·Product code LXH·May 6, 2011
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 24, 2008
URINE METER KIT WITH FOLEY CATHETER
FDA Adverse Event
Malfunction
·DEROYAL INDUSTRIES, INC.·Product code FCM·September 6, 2017
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