Prosthesis, Nose, Internal
General, Plastic Surgery · 21 CFR 878.3680
Recent MDR events
211 adverse event reports on file
- ASKUJun 4, 2026InjuryCochlear Bone Anchored Solutions Ab6000034-2026-02118
- ASKUJun 4, 2026InjuryCochlear Bone Anchored Solutions Ab6000034-2026-02117
- ASKUMay 11, 2026InjuryCochlear Bone Anchored Solutions Ab6000034-2026-01773
- ASKUMay 11, 2026InjuryCochlear Bone Anchored Solutions Ab6000034-2026-01772
- COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 4MMOct 6, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-03598
- COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 4MMOct 6, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-03597
- COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 4.5MMSep 10, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-03265
- COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 4.5MMSep 10, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-03266
- COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 3.5MMAug 14, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-02865
- ASKUFeb 24, 2025InjuryCochlear Bone Anchored Solutions Ab6000034-2025-00709
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
51 firms currently registered for this product code
Eagle Medical Packaging Sterilization, Inc.
PASO ROBLES, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Biomet Microfixation
Jacksonville, FL, US
Hanson Medical, Inc.
PASO ROBLES, CA, US
Synergy Sterilisation South Africa Proprietary Ltd
Isando Gauteng, ZA
Implantech Associates, Inc.
Ventura, CA, US
Maillefer Instruments Holding Sarl
BALLAIGUES Vaud, CH
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
BUFFALO, NY, US
Surgical Technology Laboratories Inc.
Lugoff, SC, US
Cochlear Bone Anchored Solutions Ab
Molnlycke Vastra Gotaland, SE
Cochlear Americas
Lone Tree, CO, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Midwest Sterilization Corp.
JACKSON, MO, US
510(k) clearances
42 clearances for this product code
- Cmf Medicon Surgical, Inc.Dec 12, 2024
K241253 · Medicon Epiplating System
- Southern Implants (Pty), Ltd.Dec 1, 2016
K161548 · Osseointegrated Fixtures
- Hanson Medical, Inc.Jun 30, 2010
K090803 · HANSON MEDICAL FACIAL IMPLANTS
- Nobel Biocare ABJun 2, 2009
K090630 · NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
- Hanson Medical, Inc.May 25, 2007
K071018 · MONARCH NASAL IMPLANT
- Hanson Medical, Inc.Feb 11, 2005
K041690 · MONARCH NASAL IMPLANT
- Aesthetic and Reconstructive Technologies, Inc.Jul 2, 2002
K021418 · AART NASAL IMPLANT
- Pillar Surgical, Inc.Nov 22, 1999
K992242 · PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS