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