10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CEDIA (TM) CORTISOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERA Angled 2.2mm Implant Micro 13X4mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107207·The ERA implant enables the transitional functi...
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·November 17, 2010
CORTSCR Ø4.5 SELF-TAP L50 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·January 8, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021