11 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

IMPALA CASTERS

FDA 510(k)
FDA Class 1 ·Physical Medicine

ReLine

FDA UDI
Nuvasive, Inc.·00195377069375·RELINE C Screw, 3.5x46mm FA

Fixion Nailing System

FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331270·Cortical screw for use with humeral nails

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613025557·Universal Wire Plate Scissors, Laterally Angled...

ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

FDA 510(k)
FDA Class 2 ·Orthopedic

INTERSTIM

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 12, 2010

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code LWS·July 3, 2014

CUSTOM PAK

FDA Adverse Event
Malfunction ·ALCON - HOUSTON·Product code KYG·December 21, 2012

1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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