BRACCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
BRACEUS INDUSTRIES CO., LIMITED5N2026-01-01UNIT 1021, BEVERLEY COMMERCIAL CENTRE, 87-105 CHATHAM ROAD SOUTH HK HK 999077
29537133002022541BRACESOX, THE ORIGINAL1N2026-01-012825 Porter Street, Suite A SOQUEL CA US 95073
30090457523009045752BRACELAB1Y2026-01-014700 Homewood Court Suite 112 Raleigh NC US 27609
30130028683013002868BRACE ALIGN1Y2026-01-01128 Harrison Ln Soddy Daisy TN US 37379
30154592013015459201BRACEABILITY, INC.1N2026-01-016122 Nordic Drive Cedar Falls IA US 50613
30337145193033714519BRACE BOSS, LLC1N2026-01-0111950 Barker Cypress Rd Cypress TX US 77433
30072916423007291642BRACKET USA LLC1N2020-04-259000 Sheridan Street, Suite 138 Pembroke Pines FL US 33024

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10815112020214Fast Find Grid: Disposable CT Biopsy Grid - Fast Find Grid609-514-2200xx@xx.xx
10815112021167Rounded Flexi Tip Adult Enema Tip - Rounded Flexi Tip609-514-2200xx@xx.xx
10815112021174Enema Kit: Empty Enema Bag Delivery System - Empty Snap Cap Bag609-514-2200xx@xx.xx
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff - Non latex Retention Enema Tip609-514-2200xx@xx.xx
10815112021198Miller Enema Air Tip with Retention Cuff - Non latex Air Retention Tip609-514-2200xx@xx.xx
30815112021291High Pressure Hose and Yoke - 710603609-514-2200xx@XX.XX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
958221814925614K090567ORTHODONTIC CERAMIC BRACKETNJM2009-05-27
549511049726243
958221203590188
958221623776468
958221797421431
958222001097848
1979871025585275
1979871037542227
1979871046367464
2303261073048559
3503831159925631
1979871200598752
3503831241748352
3503831256678514
1979871284091139
2303261311414938
1979871322571560
2303261327247292
1979871365102802
1979871383445051
1979871383895502
1979871405315756
1979871407790156
1979871412761769
3503831413337989
2303261422295522
2303261489507649
1979871517442206
1979871550882496
2303261560397540
2303261581545771
1979871609454532
3503831618990013
1979871623157831
2303261639477732
3503831639711814
2303261684872570
2303261689347262
1979871698906513
1979871706653163
2303261706932698
1979871709341395
1312841713317737
1979871716620858
2303261719191200
2303261743297785
3503831761643501
1979871791594733
3319961847378539
3503831864981554
2303261891643948
3503831897212025
2303261906291351
2303261943799528
2303261946021496
1979871960249988
1979871963275996
1979871969425564
2303261981340966
3503832045661695

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NJM12009-05-27

NDC#

Choletec

Bracco Diagnostics Inc

Mebrofenin

Gastrografin

Bracco Diagnostics Inc

diatrizoate meglumine and diatrizoate sodium

KINEVAC

Bracco Diagnostics Inc.

sincalide

ProHance

Bracco Diagnostics Inc

gadoteridol

ProHance

BRACCO DIAGNOSTICS INC

gadoteridol

ISOVUE

BRACCO DIAGNOSTICS INC

IOPAMIDOL

ISOVUE

Bracco Diagnostics Inc

IOPAMIDOL

ISOVUE

BRACCO DIAGNOSTICS INC

IOPAMIDOL

ISOVUE

BRACCO DIAGNOSTICS INC

IOPAMIDOL

ISOVUE

Bracco Diagnostics Inc

IOPAMIDOL

ISOVUE

BRACCO DIAGNOSTICS INC

IOPAMIDOL

MultiHance

BRACCO DIAGNOSTICS INC

gadobenate dimeglumine

MultiHance

BRACCO DIAGNOSTICS INC

gadobenate dimeglumine

Vueway

BRACCO DIAGNOSTICS INC

Gadopiclenol

IOMERVU

BRACCO DIAGNOSTICS INC

Iomeprol Injection

IOMERVU

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Vueway

BRACCO DIAGNOSTICS INC

Gadopiclenol

Vueway

BRACCO DIAGNOSTICS INC

Gadopiclenol

Vueway

BRACCO DIAGNOSTICS INC

Gadopiclenol

Vueway

BRACCO DIAGNOSTICS INC

Gadopiclenol

Lumason

BRACCO DIAGNOSTICS INC

SULFUR HEXAFLUORIDE

LumaSon

BRACCO DIAGNOSTICS INC

SULFUR HEXAFLUORIDE

LumaSon

BRACCO DIAGNOSTICS INC

SULFUR HEXAFLUORIDE

LumaSon

BRACCO DIAGNOSTICS INC

SULFUR HEXAFLUORIDE

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

Iomeron

BRACCO DIAGNOSTICS INC

Iomeprol Injection

PMN#

Applications#

44 records. Showing 1-40. Next

GUDID#

92 records. Showing 1-40. Next