22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATAMA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Automix-Dispenser Type 50 10:1
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1104111·Automix-Dispenser, Type 50 10:1. Suitable for: ...
C-5 (b1f) RID plate package
FDA UDI
KENT LABORATORIES INC·B1761104·Radial immunodiffusion plate package for Human ...
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989028287·TMA BROAD ARCH LO LGE 0175 0175 PK/10
IMAGEN Parainfluenza Virus Types 1, 2 and 3
FDA UDI
OXOID LIMITED·05032384502974·
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100110·Tray Insert, Rod Connectors
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100110·Tray Insert 4, Cosmolock, Arcamed
VARIOUS DENTAL IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 6, 2023
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·August 10, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·September 23, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 9, 2011
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 13, 2011
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·September 13, 2011
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017