10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PACING/PSI KIT: 5 FR/6 FR 2-L
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SEMEN ANALYSIS KIT
FDA 510(k)
FDA Class 2
·Hematology
4.9MM TI LOCKING BOLT 42MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·July 10, 2019
ARTICUL/EZE BALL 32 +5 BR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·December 30, 2010
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·January 31, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 18, 2014
PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015