12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENDO-MARYLAND DISSECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304233041·
7141794
FDA Adverse Event
Malfunction
·December 22, 2017
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ATLANTIS 018 PERIPHERAL IMAGING CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code ITX·June 27, 2011
PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. 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