11 results · 20ms · Sources: EU EUDAMED, 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