11 results · 21ms · 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.

VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450748787·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450547380·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450545744·

VITALSAT PULSE OXIMETER, MODEL IC32000

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRIMA III TOTALSENSE TORSO COIL

FDA 510(k)
FDA Class 2 ·Radiology

3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 24MM

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HWC·May 3, 2013

TENDRIL STS

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 14, 2014

DRILL, AO 4,2X340 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·May 5, 2011

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012