9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL ELECTRICAL PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IBALANCE TKA TIBIAL TRAY SIZE 4
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code JWH·January 13, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·June 30, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 14, 2013
ECHELON*FLEX45 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 3, 2010
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. 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
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016