13 results
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20ms
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Sources: EU EUDAMED, US FDA
IBA PROTON THERAPY SYSTEM - PROTEUS 235
FDA 510(k)
FDA Class 2
·Radiology
LITE STRAIGHT PLATE, 13-HOLE
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665031973·
SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES
FDA 510(k)
FDA Class 2
·Physical Medicine
CLEARFIL ST OPAQUER
FDA 510(k)
FDA Class 2
·Dental
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 16, 2013
GPS PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·March 18, 2011
MITEK FMS PUMP
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·June 16, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 25, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code NKB·October 8, 2010
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015