125 results · 22ms · Sources: EU EUDAMED, 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