11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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G7 OSSEOTI ACETUBLAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CERAFORM BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
FETAL SPIRAL ELECTRODE
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code HGP·November 24, 2014
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021
TWIST DRILL-1.5MMX6MM SCRW
FDA Adverse Event
Malfunction
·DEPUY SNYTHES POWER TOOLS·Product code HSZ·May 31, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 15, 2011
AUTOMATIC ENDOSCOPE REPROCESSOR
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code FEB·August 28, 2008
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020