11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 12, 2019
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370670·STRETCHER PAD 28" W X 3.5" H X 74" L DELUXE
Guedel Airways
FDA UDI
MERCURY ENTERPRISES, INC.·10641043812600·
ALLROUND 55 LF
FDA 510(k)
FDA Class 2
·Dental
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·April 26, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·April 26, 2011
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·July 23, 2008
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·March 22, 2017
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