FDA.reportPublic FDA data

American Medicals

Primary DI
B356JD259280
Brand
American Medicals
Company
American Medicals
Model
1
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXDClamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXDClampGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356JD259280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery clampA hand-held, manual surgical instrument designed to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). It may be referred to as a clip or a clamp, is made of plastic, and has a self-retaining design; it is not in the form of a bulldog clamp nor scissors-like forceps. This is a single-use device.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
109909627
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B356FF192040American Medicals12022-09-26
B35645724070American Medicals12022-09-09
B356FF701020American Medicals12026-07-14
B356JB405140American Medicals12026-07-06
B356BK211110American Medicals12026-05-29
B356KE392100American Medicals12026-05-29
B356KE396100American Medicals12026-05-29
B35675400020American Medicals12026-05-20
B35675440110American Medicals12026-05-20
B356BH414050American Medicals12026-05-06
B356KB074090American Medicals12026-05-06
B356KF251020American Medicals12026-04-15
B356KF251040American Medicals12026-04-15
B356ED469970American Medicals12026-04-07
B356ED470040American Medicals12026-04-07
B356ED470050American Medicals12026-04-07
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9017971000Surgical DirectSurgical Direct, Inc.HXD2026-08-21
00190776426606MillenniumAvalign Technologies, Inc.HXD2026-08-19
00840277133779Innomed, Inc.INNOMED, INC.HXD2026-08-18
00840277133786Innomed, Inc.INNOMED, INC.HXD2026-08-18
05060624127007CS Mayfield / Doro AdaptorsCARE SURGICAL LIMITEDHXD2026-08-07
00190776405786MillenniumAvalign Technologies, Inc.HXD2026-07-24
04058749047981NAFehling Instruments GmbH & Co. KGHXD2026-07-17
B8034503260ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503660ORTHOMEDORTHO-MED, INC.HXD2026-07-14
B8034503700ORTHOMEDORTHO-MED, INC.HXD2026-07-14
00840277133656Innomed, Inc.INNOMED, INC.HXD2026-05-29
ESAM3840131STOMA®Storz am Mark GmbHHXD2025-04-30
ESAM3841131STOMA®Storz am Mark GmbHHXD2025-04-30
00840314269690gSourceGSOURCE LLCHXD2025-01-15
00840314269591gSourceGSOURCE LLCHXD2024-08-14
10840199539571Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539588Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539595Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539601Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539618Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539625Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539632Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199539649Glover BulldogKOROS U.S.A., INC.HXD2024-02-02
10840199535894ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535948Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535955Cardio ClampKOROS U.S.A., INC.HXD2024-01-31
10840199535979Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536013Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536020Aortic ClampKOROS U.S.A., INC.HXD2024-01-31
10840199536037Aortic ClampKOROS U.S.A., INC.HXD2024-01-31