10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Minhua Disposable Blood Pressure Cuff
FDA 510(k)
FDA Class 2
·Cardiovascular
Headless Compression Screw
FDA UDI
I.T.S. GmbH·09120047297568·Headless Compression Screw, Cannulated, D=4.3mm...
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
RETRIEVAL BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017
AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·October 6, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·June 3, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 29, 2011
PKG, BABCOCK FORCEPS, P/N 0250080321. 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
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015