10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFANT FLOW SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE O.R. TOWEL, STERILE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RESORBABLE BONE PLUG
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 4, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 21, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 4, 2011
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 13, 2017
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 13, 2017
TAPERLOC POR FMRL 9X137
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 13, 2017
PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 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