16 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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SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General Hospital
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70612401·BioQuick-Brackets FACE Evolution II System .018...
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0162400·Tamp, Bone Funnel
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197028400·Siebold gynaecological scissors
s-curv...
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481475258·
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523159215·4.0mm x 14mm Fixed Angle, Self Drilling
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523159222·4.0mm x 16mm Fixed Angle, Self Drilling
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523159208·4.0mm x 12mm Fixed Angle, Self Drilling
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523159239·4.0mm x 18mm Fixed Angle, Self Drilling
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNL·April 16, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008
6.0MM TI SOFT ROD 50MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNH·April 11, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015