Atlas FDA

FZE

42 FDA 510(k) clearances · Product code

64 daysmedian time to decision
197 days90th percentile
42clearances measured

FDA profile

Official device name
Prosthesis, Nose, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3680
Medical specialty
General, Plastic Surgery
Flags
Implant
Adverse events (MAUDE)
2018: 12 · 2019: 24 · 2020: 23 · 2021: 32 · 2022: 30 · 2024: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Medicon Epiplating System (K241253)Cmf Medicon Surgical, Inc.2024-12-12
Osseointegrated Fixtures (K161548)Southern Implants (Pty), Ltd.2016-12-01
HANSON MEDICAL FACIAL IMPLANTS (K090803)Hanson Medical, Inc.2010-06-30
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (K090630)Nobel Biocare AB2009-06-02
MONARCH NASAL IMPLANT (K071018)Hanson Medical, Inc.2007-05-25
MONARCH NASAL IMPLANT (K041690)Hanson Medical, Inc.2005-02-11
AART NASAL IMPLANT (K021418)Aesthetic and Reconstructive Technologies, Inc.2002-07-02
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (K992242)Pillar Surgical, Inc.1999-11-22
NASAL DORSAL SERIES (K983755)Surgical Technology Laboratories, Inc.1998-11-20
SEARE BIOMEDICAL NASAL IMPLANTS (K982753)Seare Biomedical Corp.1998-09-30
SILIMED NASAL L SHAPED IMPLANT (K981833)Silimed, LLC1998-06-26
DURALASTIC ANATOMICAL NASAL IMPLANTS (K973573)Hanson Medical, Inc.1997-11-13
DURALASTIC ANATOMICAL NASAL IMPLANTS (K971481)Allied Biomedical Corp.1997-07-18
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT (K962824)Implantech Associates, Inc.1996-10-03
THE NAUTILUS (K961124)Rand Scientific Corp.1996-04-19
SILICONE ELASTOMER MALAR IMPLANT (K952707)Spirit Ridge Technologies1995-08-28
PROTHESIS, CHIN, INTERNAL (K952709)Spirit Ridge Technologies1995-08-28
SPIRIT RIDGE SILICONE CARVING BLOCK (K952706)Spirit Ridge Technologies1995-08-28
PECTORALIS IMPLANT (K952708)Spirit Ridge Technologies1995-08-28
SPIRIT RIDGE NASAL IMPLANT (K952705)Spirit Ridge Technologies1995-08-28
BA-CPAS (K945154)Nobelpharma USA, Inc.1995-01-13
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II (K941960)Implantech Associates, Inc.1994-08-17
IMPLANTECH DORSAL NASAL IMPLANT (K942876)Implantech Associates, Inc.1994-07-18
NASAL DORSUM (K925743)Smith & Nephew Richards, Inc.1993-08-10
RIZZO NASAL IMPLANT (K925426)Implantech Associates, Inc.1993-05-12
BRINK PRE-MAXILLARY IMPLANT (K921580)Implantech Associates, Inc.1992-05-06
FLOWERS NASAL IMPLANT (K904656)Implantech Associates, Inc.1990-12-18
FLOWERS DORSAL COLUMELLA IMPLANT (K904657)Implantech Associates, Inc.1990-12-18
CUI DORSAL COLUMELLA PROSTHESIS (K904350)Cui Corp.1990-11-26
CUI PREMAXILLARY IMPLANT (K903328)Cui Corp.1990-09-10
THE NAUTILUS NASAL IMPLANT (K902283)Applied Biomaterial Technologies1990-08-14
SILASTIC NASAL IMPLANT S-TYPE (K880405)Dow Corning Wright1988-02-18
OMEGA DORSAL COLUMELLA IMPLANTS (K871071)Omega Silicone, Inc.1987-04-13
POREX(TM) NOSE PROSTHESIS (K863942)Porex Medical1986-10-24
BYRON BIVALVE NASAL SPLINTS (K863430)Byron Medical1986-09-17
BYRON DORSAL COLUMELLA IMPLANT (K863399)Byron Medical1986-09-17
BYRON NASAL SEPTAL BUTTON (K863398)Byron Medical1986-09-17
CUI RHINOPLASTY IMPLANTS (K853945)Cox-Uphuff Intl.1985-10-18
FRANCIS NASAL TUBE (K822130)Tekna Med Corp.1982-10-13
STRAITH NASAL IMPLANT (K801074)Surgical Technology Laboratories, Inc.1980-06-17
PASTE, PRO CARE PROPHYLAXIS (K782104)Young Dental Manufacturing Co. 1, LLC1979-01-03
PLASTI-PORE SEPTAL BUTTON (K781574)Richard'S Medical Equip., Inc.1978-09-27

Track FZE automatically

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