Atlas FDA

DWZ

23 FDA 510(k) clearances · Product code

84 daysmedian time to decision
191 days90th percentile
23clearances measured

FDA profile

Official device name
Device, Biopsy, Endomyocardial
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4075
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2003: 1 · 2005: 7 · 2006: 6 · 2007: 2 · 2010: 3 · 2022: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Biopsy Forceps (K252722)Fehling Instruments GmbH2025-09-30
Biopsy Forceps (K170726)Fehling Instruments GmbH & Co. KG2017-06-02
NOVATOME, MODEL: SU101-50 (K072051)Scholten Surgical Instruments, Inc.2007-10-03
SPARROWHAWK DISPOSABLE (K010473)Atc Technologies, Inc.2001-06-06
MODIFICATION TO T-REX BIOPSY FORCEPS (K000409)Boston Scientific Corp2000-02-28
ULTRA-CBX (K991486)Medcanica, Inc.1999-11-05
T-REX BIOPSY FORCEPS (K973818)Boston Scientific Corp1997-12-16
HEARTPORT ENDOAORTIC CLAMP CATHETER (K974175)Heartport, Inc.1997-12-16
DYNABITE CARDIOVASCULAR BIOPSY FORCEPS (K951447)Portlyn Corp.1995-07-27
CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF (K933235)Cordis Corp.1994-01-06
CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE (K932788)Cordis Corp.1993-09-01
BIOPSY FORCEPS (K921401)Annex Medical, Inc.1992-10-21
CORDIS BIPAL 7 BIOPSY FORCEPS (K920289)Cordis Corp.1992-03-30
CORDIS BIPAL BIOPSY FORCEPS (K914567)Cordis Corp.1991-12-18
VASCULAR BIOPSY FORCEPS (K910840)Vascular Products, Inc.1991-07-15
BIOPSY FORCEPS (K901300)Portlyn Corp.1990-06-29
BIOPSY FORCEPS (K895098)Annex Medical, Inc.1989-10-30
REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES (K890453)Dlp, Inc.1989-03-31
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS (K883723)Cook, Inc.1988-12-05
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES (K882383)CIVCO Medical Instruments Co., Inc.1988-11-28
MYOCARD BIOPSY FORCEP (K881412)Fehling Medizintechnik GmbH1988-09-08
ENDOMYOCARDIAL BIOPSY DEVICE (K870186)Mansfield Scientific, Inc.1987-02-20
CORDIS BIOPSY FORCEPS (K810849)Cordis Corp.1981-04-17

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Every clearance here is in the API, with alerts when new ones post.