15 results · 21ms · Sources: EU EUDAMED, US FDA

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KODAK AUTOMATIC FILM FEEDER, MODEL RA

FDA 510(k)
FDA Class 2 ·Radiology

JOURNEY II BCS KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

JRNY BCS PAT RESRF RD 35 MM STD

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018

PROXIMATE*ILS CURVED CIR STAPL

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 1, 2010

TELIGEN

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013

VENTAK PRIZM

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

JOURNEY POLY TIBIAL INSERT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022

PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019

Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014