9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Stage-1
FDA UDI
KEYSTONE DENTAL, INC.·D768S2418131K0·Abutment Driver
RHYTHMSTAR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GE LOGIQ 7 ULTRASOUND BT04
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 10, 2025
SILIC FOLEY CATH 5/15 ML/5
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code EZL·September 9, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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