12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
FDA 510(k)
FDA Unclassified
·Unknown
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112670·BARRON CORNEAL PUNCH 9.0MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)
OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 17, 2016
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
LID F/BATT-HANDPIECE NO. 05.001.201 F/TR
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·July 2, 2013
K-WIRE 2 L280 SST 10U
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTY·April 30, 2021
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
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012