9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DePuy Synthes MAXFRAME Multi-Axial Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INQUIRY
FDA Adverse Event
Malfunction
·STRYKER SUSTAINABILITY SOLUTIONS·Product code DSA·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT
FDA Adverse Event
STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·October 6, 2016
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017