22 results · 22ms · Sources: EU EUDAMED, US FDA

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AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58280140810·CURETTE

Tandem Mobi Starter Kit

FDA UDI
Tandem Diabetes Care, Inc.·00389152408170·with Control-IQ 7.X

24M - RJ Corman - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588140810·24M - RJ Corman - Metal

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563267·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033582701·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563298·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563281·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563243·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563250·

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033563274·

RADIESSE DERMA FILLER

FDA Adverse Event
Injury ·BIOFORM MEDICAL, INC.·Product code LMH·January 26, 2010

ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

GOOD SAM CINCINNATI OH 1

FDA Adverse Event
Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081

FDA Enforcement
Class I ·Ongoing·Tandem Diabetes Care, Inc.·November 12, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

TENDRIL ST

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

ACCU-CHEK SPIRIT ADAPTER

FDA Adverse Event
Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 14, 2008

TITANIUM SCREW LOW PROF 5X40MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code HSD·May 10, 2013