14 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CALIBRATION PLASMA LMW HEPARIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANATOMIC PEEK PTC Cervical Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169357457·CAGE 5030964 ANATOMIC PTC 16X14X9MM
Cusco Medium w/Side Screw
FDA UDI
MEDGYN PRODUCTS, INC.·M803030964·Cusco Medium w/Side Screw 1 3/8" x 4" (35mm x 1...
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
FDA 510(k)
FDA Class 2
·Cardiovascular
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
FDA 510(k)
FDA Class 2
·Anesthesiology
FATHOM GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2013
ECHELON 60
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 28, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·April 17, 2008
LINER NEUTRAL 36 MM I.D. SIZE D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·December 14, 2020
DOWNSTREAM® SYSTEM
FDA Adverse Event
Injury
·THEROX INC·Product code MWG·April 1, 2023
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·SALT LAKE CITY·Product code DQX·February 23, 2010
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