23 results
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35ms
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Sources: EU EUDAMED, US FDA
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMARC ® EX
FDA UDI
Carbon Medical Technologies, Inc.·00850002461305·FIDUCIAL MARKER SYSTEM
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120401651·Abrasive, green, medium grit
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659204959·Schanz screw,triangular end _x000D_...
Schanz screw,triangular end 200mm/5.0mm
FDA UDI
mahe medical gmbh·EMAH00401650500·Schanz screw,triangular end
200mm/...
ERO SCAN OAE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
PYROPLAST POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI100401650·PYROPLAST POWDER 1 OZ SHADE 65
NAMILON POWDER
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI200401650·NAMILON POWDER 1 OZ SHADE 65
C & B FORMULA
FDA UDI
AMERICAN TOOTH INDUSTRIES·D772ATI400401650·C & B FORMULA 1 OZ SHADE 65
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007
SONA PILLOW
FDA Adverse Event
Other
·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007
STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·February 28, 2020
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 8, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 5, 2011
PORTRAIT PSR3
FDA Adverse Event
Injury
·RHYTEC, INC.·Product code GEI·May 9, 2008
BiomarC EX Fiducial Marker System, Catalog Number 040165
FDA Recall
Open, Classified
·Carbon Medical Technologies, Inc.·Product code IYE·July 26, 2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
FDA Enforcement
Class III
·Ongoing·Carbon Medical Technologies, Inc.·September 25, 2024
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016