17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SLIP JOINT PLIERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RECOMB ECG PREAMPLIFIER/206 069 03
FDA 510(k)
FDA Class 2
·Cardiovascular
MAGNE-DENT
FDA 510(k)
FDA Class 1
·Dental
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·January 20, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 27, 2015
ESSURE
FDA Adverse Event
Injury
·BAYER·Product code HHS·April 9, 2014
2.7X10MM HT X-DRIVE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·June 3, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 12, 2012
HAKIM PROG VALVE INLINE SIPHONGUARD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC MEDOS S.A.·Product code JXG·September 23, 2010
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 20, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 28, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 17, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 27, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 30, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 7, 2023
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 15, 2015