13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAXI ENDOSCOPIC GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Keystone HB VPS
FDA UDI
Keystone Industries·H66860817081·HB VPS Heavy Body Reg Set
Stamey
FDA UDI
COOK INCORPORATED·00827002151437·Stamey Percutaneous Loop Suprapubic Catheter Set
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
PROFOX SOFTWARE, MODEL 920M-41
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VISION HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011
PVA FOAM EMBOLIZATION PARTICLES
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 26, 2018
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·April 12, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·July 25, 2008
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018