Retractor, Self-Retaining, For Neurosurgery
Regulation 882.4800
1510(k)s in 12 months (44 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in GZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Nico Corporation | 3 | 3 |
| Ohio Medical Instrument Co., Inc. | 2 | 1 |
| Vycor Medical, Inc. | 2 | 1 |
| Johnson & Johnson | 2 | 0 |
| Medical Equipment Development Co., Inc. | 2 | 0 |
| T. Korossurgical Instruments Corp. | 2 | 0 |
| A. Henniss | 1 | 0 |
| Abbott Spine | 0 | 1 |
| Baxter Healthcare Corp | 1 | 0 |
| Bright Medical Instruments | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 17, 2026 | K252995 | Durashield Device Kit SurGenTec, LLC | GZT |
| May 13, 2022 | K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) Thompson Surgical Instruments, Inc. | GZT |
| Jan 14, 2021 | K202694 | Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family Vycor Medical, Inc. | GZT |
| Aug 26, 2020 | K202072 | MindsEye Expandable Port Minnetronix Neuro, Inc. | GZT |
| Aug 29, 2018 | K180610 | Geister retractor for neuro - and spine surgery Geister Medizin Technik GmbH, DE | GZT |
| Sep 7, 2017 | K172433 | NICO BrainPath Nico Corporation | GZT |
| Mar 24, 2017 | K161680 | MEDICON Spinal Spreading Systems Medicon EG, DE | GZT |
| Mar 20, 2017 | K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems Tedan Surgical Innovations, LLC | GZT |
| Sep 9, 2016 | K161004 | Self-retaining Retractor Fetzer Medical GmbH & Co. KG, DE | GZT |
| Jun 12, 2015 | K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook Nico Corporation | GZT |
| Jun 5, 2012 | K120691 | BRAIN PORT Nico Corporation | GZT |
| Jan 27, 2012 | K113273 | SPOTLIGHT ACCESS SYSTEM Johnson & Johnson | GZT |
| Dec 16, 2011 | K112913 | SPOTLIGHT ACCESS SYSTEM Johnson & Johnson | GZT |
| Nov 15, 2010 | K093054 | SCALP DURA RETRACTOR, MODEL KS00474 KARL STORZ Endoscopy-America, Inc. | GZT |
| Mar 18, 2009 | K090272 | SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES) Cardinal Health, Inc. | GZT |
| Aug 2, 2007 | K071771 | INSTRUMED RETRACTORS Instrumed International, Inc. | GZT |
| May 29, 2007 | K071338 | FLEX ARM RETRACTOR SYSTEM Koros USA, Inc. | GZT |
| Dec 15, 2006 | K062814 | PIPELINE II ACCESS SYSTEM Depuy Spine, Inc. | GZT |
| Jul 26, 2006 | K060973 | VYCOR SURGICAL ACCESS SYSTEMS Vycor Medical, LLC | GZT |
| Feb 27, 2006 | K060097 | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 KLS-Martin L.P. | GZT |
| Apr 15, 2005 | K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES Spinal Concepts, Inc. | GZT |
| Oct 21, 1999 | K992898 | THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM Bright Medical Instruments | GZT |
| Jan 23, 1997 | K964402 | VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM V. Mueller Neuro/Spine | GZT |
| May 17, 1996 | K960807 | TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 Ohio Medical Instrument Co., Inc. | GZT |
| Jan 13, 1995 | K945040 | HAMID HOOK ATTACHMENT DEVICE FOR HEMILAMINECTOMY RETRACTOR Hamid M. Mehdizadeh, M.D. | GZT |
| Mar 22, 1994 | K935529 | CERVICAL SELF-RETAINING RETRACTOR T. Korossurgical Instruments Corp. | GZT |
| Mar 1, 1994 | K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED Graham-Field, Inc. | GZT |
| Jul 31, 1991 | K913233 | CODMAN LHALO SPLIT RING RETRACTOR SYSTEM Codman & Shurtleff, Inc. | GZT |
| Apr 1, 1991 | K910621 | BLADES FOR SPINAL LAMINECTOMY RETRACTOR International Hospital Supply Co. | GZT |
| Jan 25, 1991 | K905445 | ADSON-BECKMAN RETRACTOR, SPINAL A. Henniss | GZT |
| Jul 3, 1990 | K902517 | NEUROSURGICAL HEADFRAME ACCESSORIES Sims Surgical, Inc. | GZT |
| Jan 19, 1990 | K885120 | ESI MODEL MS-103 Electrical Systems Div. | GZT |
| Dec 6, 1989 | K896156 | COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM Stereotactic Medical Systems, Inc. | GZT |
| Oct 19, 1989 | K895395 | V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR Baxter Healthcare Corp | GZT |
| Sep 22, 1989 | K895537 | MODIFIED MEMORY RETRACTOR ARM Medical Equipment Development Co., Inc. | GZT |
| May 5, 1989 | K892543 | NEUROSURICAL RETRACTORS - VARIOUS TYPES Zinnanti Surgical Instruments, Inc. | GZT |
| Jun 10, 1988 | K882071 | CRANK FRAME RETRACTOR Karlin Technology, Inc. | GZT |
| Apr 6, 1988 | K881160 | CRANK FRAME RETRACTOR T. Korossurgical Instruments Corp. | GZT |
| Mar 24, 1988 | K874829 | MEDCO MEMORY RETRACTOR SYSTEM Medical Equipment Development Co., Inc. | GZT |
| Jan 28, 1988 | K874956 | SELF-RETAINING RETRACTOR FOR NEUROSURGERY Solway, Inc. | GZT |
| Sep 28, 1987 | K873691 | CEDAR(TM) RETRACTOR RING Cedar Surgical, Inc. | GZT |
| Mar 2, 1983 | K830332 | BUDDE-HALO RETRACTOR Ohio Medical Instrument Co., Inc. | GZT |
| Aug 13, 1980 | K801855 | CYCLOPAC TENS Dow Corning Wright | GZT |
| May 20, 1980 | K801151 | DISPOSABLE SKIN RETRACTOR Cimarron Instruments, Inc. | GZT |
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