16 results · 19ms · Sources: EU EUDAMED, US FDA

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Audit MicroControls Control FD Assayed Chemistry, Level 1

FDA UDI
AALTO SCIENTIFIC·B085K0311100·

APEX MODULAR ACETABULAR CUP

FDA 510(k)
FDA Class 2 ·Orthopedic

MATIRA ANTERIOR CERVICAL SYSTEM

FDA UDI
Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED

Zavation

FDA UDI
Zavation LLC·00842166178519·Set of blades 110mm lateral

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece

HammerTech

FDA UDI
FUSION ORTHOPEDICS, LLC·00819034027095·HT PEEK Driver Petite

CRYSTAL-EEG MODEL 15

FDA 510(k)
FDA Class 2 ·Neurology

M2A ACETABULAR SYSTEM

FDA 510(k)
FDA Class 3 ·Orthopedic

PFC SIGMARP CV TB/IN S3 12.5

FDA Adverse Event
Injury ·DEPUY IRELAND ? REG. # 9616671·Product code NJL·April 2, 2013

V.A.C THERAPY SYSTEM

FDA Adverse Event
Injury ·KCI USA, INC.·Product code OMP·March 22, 2011

GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

FDA Adverse Event
Injury ·GUIDANT CARDIAC SURGERY·Product code DXC·April 18, 2008

M2A ACETABULAR COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

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

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016