12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704920881·
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704284393·BECKMAN-ADSON RETRACTOR 1"x1" SHARP
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098605·Beckman Adson Retractor
ORION DIGITAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® INFORM BASE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·April 11, 2013
SELOX ST 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·March 15, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 2, 2014
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015