8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS
FDA 510(k)
FDA Class 1
·Dental
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE TVT DEVICE
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 8, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 21, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 17, 2014
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 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