12 results · 21ms · Sources: EU EUDAMED, 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