14 results · 31ms · Sources: EU EUDAMED, 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