14 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PULPDENT FLUORIDE VARNISH
FDA 510(k)
FDA Class 2
·Dental
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127628·AK3 PS Insert Trial Size 6, 20mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450562901·
BD INSULIN¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 19, 2018
BD INSULIN¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 1, 2018
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
FDA 510(k)
FDA Class 2
·Radiology
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code NDJ·May 6, 2013
M2A-MAGNUM PF CUP 60ODX54ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 16, 2014
INOMAX DS (DELIVERY SYSTEM)
FDA Adverse Event
Malfunction
·INO THERAPEUTICS LLC/IKARIA·Product code MRP·April 6, 2011
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
FDA Enforcement
Class I
·Terminated·Stryker Spine·August 28, 2013
BD INSULIN¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 24, 2018
INNOVANCE D-DIMER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·July 14, 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