17 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pinnacle Radiation Therapy Planning System
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694014786·SpectrumTM LeFort III, Medium Activation Rod
SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IFS PROFILE PLATES, SCREWS, AND WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)·Product code LWR·September 11, 2017
PERCOR STAT DL 9.5 FR. 34 CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 3, 1997
MINILINK TRANSMITTER
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·October 14, 2014
RENAISSANCE 29 P-WASHOBS10/04
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 14, 2013
PERCDLE DEVICE CONVENIENCE PACK
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·June 17, 2011
ALPHA I INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·September 26, 1997
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
QUADRA H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 20, 2024
ACE LINR-NEUT-40X58/60 RESTORIS XLVE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OQG·November 24, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012