10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bio2 CLM BG Bioactive Scaffold
FDA 510(k)
FDA Class 2
·Orthopedic
GOOD NIGHT
FDA 510(k)
FDA Class 2
·Dental
HOLTER PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
EFFERDENT
FDA Adverse Event
Injury
·PRESTIGE BRAND HOLDINGS, INC.·Product code EFT·April 18, 2013
ENDOPATH ETS COMPACT-FLEX 45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC JOHNSON AND JOHNSON COMPANY·Product code GDW·June 22, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
TFE Coated Curved Newton LLT
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 21, 2018
Newton Wire Guide
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 21, 2018
PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. 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
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015