23 results · 35ms · Sources: EU EUDAMED, US FDA

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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