125 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DX-D IMAGING PACKAGE
FDA 510(k)
FDA Class 2
·Radiology
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564034069·REX VEIN STRIPPING TRAY
Kirwan
FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019102824·Bipolar Coagulation Forceps 4 1/4" (10.8cm) Coa...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197039048·Super-Cut Strabismus Scissor
curved...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
TOTAL FEMUR
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 7, 2018
CATALYS SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code OOE·October 30, 2015
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
FDA Adverse Event
C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 20, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·September 26, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2011
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·March 14, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 10, 2016
CATALYS SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code OOE·February 11, 2016
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·August 8, 2012
CATALYS SYSTEM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·July 13, 2018