Device, Biopsy, Endomyocardial
Cardiovascular · 21 CFR 870.4075
Recent MDR events
89 adverse event reports on file
- BIOPSY FORCEPJul 10, 2026InjuryCordis Us. Corp1016427-2026-00063
- BIOPSY FORCEPJul 8, 2026MalfunctionCordis Us Corp.1016427-2026-00054
- BIOPSY FORCEPJun 22, 2026MalfunctionCordis Us. Corp1016427-2026-00048
- BIOPSY FORCEPMar 9, 2026MalfunctionCordis Us. Corp1016427-2026-00014
- BIOPSY FORCEPJan 16, 2025InjuryCordis Us Corp1016427-2025-00002
- BIOPSY FORCEPJun 18, 2024InjuryCordis Us. Corp1016427-2024-00015
- ENDOMYCARDIAL BIOPSY FORCEPSJun 17, 2024MalfunctionSt. Jude Medical, Cardiology Division, Inc.MW5156340
- JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 5F X 105CM STRAIGHTMay 1, 2024InjuryArgon Medical Devices0001625425-2024-01005
- JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVEDApr 1, 2024MalfunctionArgon Medical Devices0001625425-2024-00974
- PROCURE ENDOMYOCARDIAL BIOPSY FORCEPSDec 22, 2023MalfunctionSt. Jude Medical3005334138-2023-00586
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
29 firms currently registered for this product code
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
St. Jude Medical, Cardiology Division, Inc.
Plymouth, MN, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Viant As&o Holdings, Llc
LACONIA, NH, US
Isomedix Operations Inc
EL PASO, TX, US
Argon Medical Devices Inc.
ATHENS, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Atc Technologies Inc.
Wilmington, MA, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Isomedix Operations Inc
El Paso, TX, US
Fehling Instruments Gmbh
KARLSTEIN Bavaria, DE
St. Jude Medical, Atrial Fibrillation Division, Inc.
Minnetonka, MN, US
Guenter Stoffel Medizintechnik Gmbh
WURMLINGEN Baden-Wurttemberg, DE
Merit Medical Uk Limited
Earley Reading, GB
Lake Region Medical
CHASKA, MN, US
Sterigenics U.s., Llc
Corona, CA, US
Merit Medical Systems, Inc.
South Jordan, UT, US
Cordis Us Corp.
Miami Lakes, FL, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Norman Noble, Inc.
Highland Heights, OH, US
Pfm Medical, Inc
Carlsbad, CA, US
510(k) clearances
23 clearances for this product code
- Fehling Instruments GmbHSep 30, 2025
K252722 · Biopsy Forceps
- Fehling Instruments GmbH & Co. KGJun 2, 2017
K170726 · Biopsy Forceps
- Scholten Surgical Instruments, Inc.Oct 3, 2007
K072051 · NOVATOME, MODEL: SU101-50
- Atc Technologies, Inc.Jun 6, 2001
K010473 · SPARROWHAWK DISPOSABLE
- Boston Scientific CorpFeb 28, 2000
K000409 · MODIFICATION TO T-REX BIOPSY FORCEPS
- Medcanica, Inc.Nov 5, 1999
K991486 · ULTRA-CBX
- Boston Scientific CorpDec 16, 1997
K973818 · T-REX BIOPSY FORCEPS
- Heartport, Inc.Dec 16, 1997
K974175 · HEARTPORT ENDOAORTIC CLAMP CATHETER