Neurosurgical Paddie
Regulation 882.4700
0510(k)s in 12 months (24 all time)
2recalls in 12 months (78 all time)
74recalls that name a 510(k)
Top companies in HBA
| Company | 510(k)s | Recalls |
|---|---|---|
| American Surgical Company, LLC | 2 | 50 |
| Integra LifeSciences Corporation | 1 | 23 |
| American Silk Sutures, Inc. | 4 | 0 |
| Codman & Shurtleff, Inc. | 1 | 3 |
| Medline Industries, Inc. | 1 | 2 |
| Ultracell Medical Technologies, Inc. | 3 | 0 |
| Aesculap | 2 | 0 |
| American Surgical Sponges | 1 | 0 |
| Harod Enterprises, Inc. | 1 | 0 |
| I M, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2020 | K193346 | Codman Surgical Patties & Strips Integra LifeSciences Corporation | HBA |
| Sep 26, 2014 | K140369 | MEDLINE NEURO SPONGE Medline Industries, Inc. | HBA |
| Jun 20, 2013 | K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) American Surgical Company, LLC | HBA |
| Sep 10, 2012 | K121822 | DELICOT American Surgical Company, LLC | HBA |
| Feb 22, 2008 | K073576 | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES Harod Enterprises, Inc. | HBA |
| Sep 15, 2006 | K062406 | AESCULAP NEURO PATTIES Aesculap, Inc. | HBA |
| May 9, 2003 | K031008 | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) Aesculap | HBA |
| Jun 3, 2002 | K020736 | TRAATEK COTTONOID PATTIES Traatek, Inc. | HBA |
| Mar 27, 2002 | K014268 | NORAPAD PLAIN; NORAPAD TA Perlei Medical, Inc. | HBA |
| Mar 30, 2000 | K993019 | PACIFIC SURGICAL PATTIES V. Mueller Neuro/Spine | HBA |
| Dec 9, 1997 | K973083 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| May 2, 1997 | K962807 | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES American Surgical Sponges | HBA |
| Apr 21, 1997 | K970328 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| Aug 15, 1995 | K950647 | ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. | HBA |
| Dec 30, 1992 | K914600 | NEUROLOGICAL SPONGE I M, Inc. | HBA |
| Aug 28, 1992 | K923027 | NEURAY SURGICAL PATTIES AND STRIPS Martland Healthcare, Inc. | HBA |
| Mar 27, 1991 | K904514 | STRUNG TELFA NON-ADHERENT SPONGE American Silk Sutures, Inc. | HBA |
| Sep 18, 1990 | K902921 | RAYON NEUROLOGICAL SPONGE American Silk Sutures, Inc. | HBA |
| Mar 23, 1990 | K891993 | COLLAGEN NEUROSPONGE Vitaphore Corp. | HBA |
| Mar 2, 1988 | K880402 | CODMAN SURGICAL PATTIE Codman & Shurtleff, Inc. | HBA |
| Jul 30, 1986 | K862494 | POLYESTER SPONGE PATTIE American Silk Sutures, Inc. | HBA |
| Mar 20, 1986 | K854713 | COTTON NEUROLOGICAL SPONGE American Silk Sutures, Inc. | HBA |
| Jun 13, 1985 | K844594 | NEURO CUSTOM SURGICAL KIT Xanmed Corp. | HBA |
| Jun 20, 1977 | K770894 | NEURO-SORB PATTIES Instranetics, Inc. | HBA |
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