Cuff, Nerve
Regulation 882.5275
2510(k)s in 12 months (40 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in JXI
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 4 | 3 |
| Alafair Biosciences | 4 | 0 |
| Collagen Matrix, Inc. | 4 | 0 |
| Axogen Corporation | 3 | 0 |
| Biocircuit Technologies, Inc. | 3 | 0 |
| Cook Biotech Incorporated | 3 | 0 |
| Polyganics B.V., | 3 | 0 |
| Medovent GmbH | 2 | 0 |
| Salumedica, LLC | 2 | 0 |
| Auxilium Biotechnologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 9, 2026 | K260245 | SILKBridge KLISBio S.r.l., IT | JXI |
| Jan 17, 2026 | K253363 | NeuroSpan Bridge Auxilium Biotechnologies, Inc. | JXI |
| Jul 22, 2025 | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) Alafair Biosciences | JXI |
| Jul 17, 2025 | K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) Alafair Biosciences | JXI |
| Apr 2, 2025 | K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) Orthocell, Ltd., AU | JXI |
| Apr 2, 2025 | K242113 | Nerve Wrap (07-DW-001-TAB) Biocircuit Technologies, Inc. | JXI |
| Jun 21, 2024 | K233322 | Mochida Nerve Cuff Mochida Pharmaceutical Co., Ltd., JP | JXI |
| Feb 12, 2024 | K233533 | NerveTape Biocircuit Technologies, Inc. | JXI |
| Jan 29, 2024 | K230794 | Rebuilder Nerve Guidance Conduit Celestray Biotech Company, LLC., | JXI |
| Nov 2, 2023 | K232029 | VersaWrap Nerve Protector Alafair Biosciences, Inc. | JXI |
| Oct 12, 2023 | K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axo Axogen Corporation | JXI |
| Apr 7, 2023 | K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axo Axogen Corporation | JXI |
| Jul 15, 2022 | K210665 | Nerve Tape Biocircuit Technologies, Incorporated | JXI |
| Feb 10, 2022 | K202234 | NervAlign Nerve Cuff Renerve, Ltd., AU | JXI |
| Sep 14, 2020 | K201631 | VersaWrap Nerve Protector Alafair Biosciences, Inc. | JXI |
| May 31, 2019 | K190246 | NeuroShield Monarch Bioimplants GmbH, CH | JXI |
| Apr 24, 2018 | K180222 | Reaxon Plus Medovent GmbH, DE | JXI |
| Aug 8, 2017 | K163446 | AxoGen Nerve Cap Axogen Corporation | JXI |
| Jun 1, 2017 | K170656 | Reinforced Flexible Collagen Nerve Cuff Collagen Matrix, Inc. | JXI |
| Jan 6, 2017 | K163457 | NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation | JXI |
| Oct 31, 2016 | K162741 | AxoGuard Nerve Connector Cook Biotech Incorporated | JXI |
| Jun 22, 2016 | K152967 | NERBRIDGE Toyobo Co., Ltd., JP | JXI |
| Jan 13, 2016 | K152684 | Nerve Capping Device Polyganics Innovations BV, NL | JXI |
| Dec 2, 2015 | K143711 | Reaxon Plus Medovent GmbH, DE | JXI |
| Apr 24, 2014 | K130557 | NEURAGEN 3D Integra LifeSciences Corporation | JXI |
| Apr 3, 2014 | K131541 | FLEXIBLE COOAGEN NERVE CUFF Collagen Matrix, Inc. | JXI |
| Jan 10, 2014 | K132660 | NERVE CUFF Cook Biotech Incorporated | JXI |
| Mar 2, 2012 | K103081 | COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE Biom'Up Sas, FR | JXI |
| Oct 20, 2011 | K112267 | NEUROLAC(R) NERVE GUIDE Polyganics B.V.,, NL | JXI |
| Aug 5, 2010 | K100382 | SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 Salumedica, LLC | JXI |
| Jul 14, 2006 | K060952 | COLLAGEN NERVE WRAP Collagen Matrix, Inc. | JXI |
| May 4, 2005 | K050573 | NEUROLAC NERVE GUIDE Polyganics B.V.,, NL | JXI |
| Jul 16, 2004 | K041620 | NEURA WRAP NERVE PROTECTOR Integra Lifesciences Corp. | JXI |
| Oct 10, 2003 | K032115 | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 Polyganics B.V.,, NL | JXI |
| May 15, 2003 | K031069 | SURGISIS NERVE CUFF Cook Biotech, Inc. | JXI |
| Sep 21, 2001 | K012814 | COLLAGEN NERVE CUFF Collagen Matrix, Inc. | JXI |
| Jun 22, 2001 | K011168 | NEUROGEN NERVE GUIDE Integra Lifesciences Corp. | JXI |
| Nov 24, 2000 | K002098 | SALUMEDICA NERVE CUFF Salumedica, LLC | JXI |
| Mar 22, 1999 | K983007 | NEUROTUBE Neuroregen, LLC | JXI |
| Jul 10, 1985 | K850785 | FASTUBE NERVE REGENERATION DEVICE Research Medical, Inc. | JXI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.