Holder, Head, Neurosurgical (Skull Clamp)
Regulation 882.4460
1510(k)s in 12 months (50 all time)
1recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in HBL
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 10 | 4 |
| Pro Med Instruments GmbH | 9 | 5 |
| Ohio Medical Instrument Co., Inc. | 7 | 0 |
| Codman & Shurtleff, Inc. | 5 | 0 |
| Deerfield Imaging | 0 | 3 |
| Imris, Inc. | 3 | 0 |
| Dinkler Surgical Devices, Inc. | 2 | 0 |
| Brainlab AG | 1 | 0 |
| Downs Surgical , Ltd. | 1 | 0 |
| Engineered Orthopedic Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2025 | K250423 | mb-FIX Cranial Stabilization Systems Medical Bees GmbH, DE | HBL |
| Jul 26, 2024 | K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainl Pro Med Instruments GmbH, DE | HBL |
| Apr 24, 2024 | K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) Pro Med Instruments GmbH, DE | HBL |
| Mar 29, 2021 | K203505 | DORO QR3 Headrest System (Aluminum) Pro Med Instruments GmbH, DE | HBL |
| Jun 2, 2020 | K193438 | DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) Pro Med Instruments GmbH, DE | HBL |
| Feb 21, 2020 | K191740 | DORO LUCENT® iXI and iMRI Headrest System Pro Med Instruments GmbH, DE | HBL |
| Nov 15, 2019 | K191701 | Arcus Head Fixation Frame Mri Interventions, Inc. | HBL |
| Oct 22, 2019 | K191979 | DORO QR3 XTom Headholder System Pro Med Instruments GmbH, DE | HBL |
| Feb 23, 2017 | K163322 | TZ SKULL PIN Adult Tz Medical, Inc. | HBL |
| Nov 24, 2014 | K142238 | MAYFIELD Skull Clamp Integra LifeSciences Corporation | HBL |
| Sep 4, 2014 | K141950 | HFD100 ROCKER ARM ACCESSORY Imris, Inc. | HBL |
| Apr 26, 2013 | K122225 | STERILE RADIOLUCENT SKULL PINS Brainlab AG, DE | HBL |
| Apr 23, 2013 | K130389 | MAYFIELD INFINITY XR2 SKULL CLAMP Integra LifeSciences Corporation | HBL |
| May 24, 2012 | K120633 | MAYFIELD SKULL CLAMP Integra LifeSciences Corporation | HBL |
| Mar 23, 2012 | K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) Imris, Inc., CA | HBL |
| Mar 11, 2011 | K103493 | HEAD FIATION DEVICE (HFD 100) Imris, Inc. | HBL |
| Mar 10, 2010 | K083803 | FIXIT HEADREST CLAMP SYSTEM Medicon EG, DE | HBL |
| Aug 25, 2009 | K091439 | HEAD FIXATION ARC AND TABLE BASE Surgivision, Inc. | HBL |
| Apr 23, 2009 | K090695 | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 Dinkler Surgical Devices, Inc. | HBL |
| Apr 20, 2009 | K090506 | MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 Integra LifeSciences Corporation | HBL |
| Oct 8, 2008 | K081401 | MAYFIELD MR/X-RAY SKULL CLAMP Integra Lifesciences Corp. | HBL |
| Feb 28, 2008 | K073163 | LIMITED ARTIFACT SKULL PIN, MODEL 0107 Dinkler Surgical Devices, Inc. | HBL |
| Sep 7, 2007 | K072208 | MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS Integra LifeSciences Corporation | HBL |
| Jun 13, 2007 | K071458 | MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS Integra LifeSciences Corporation | HBL |
| May 21, 2007 | K063494 | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS Pro-Med Instruments GmbH | HBL |
| Nov 21, 2005 | K053045 | MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Integra LifeSciences Corporation | HBL |
| Sep 20, 2005 | K051440 | MAYFIELD INFINITY SKULL CLAMP Integra Lifesciences Corp. | HBL |
| Mar 31, 2005 | K050319 | MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 Integra Lifesciences Corp. | HBL |
| Nov 20, 2003 | K032331 | DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) Pro-Med Instruments GmbH | HBL |
| Aug 21, 2003 | K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX Image-Guided Neurologics, Inc. | HBL |
| Jul 29, 2002 | K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Ohio Medical Instrument Co., Inc. | HBL |
| Nov 6, 2000 | K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 Vascular Technology Incorporated | HBL |
| Aug 29, 2000 | K002276 | PSI SKULL CLAMP V. Mueller Neuro/Spine | HBL |
| Aug 4, 2000 | K001808 | DORO HEADREST SYSTEM Pro-Med Instruments GmbH | HBL |
| Sep 12, 1996 | K955012 | MIZUHO RADIOLUCENT HEAD FRAME Mizuho America, Inc. | HBL |
| Feb 9, 1996 | K953124 | MAYFIELD RADIOLUCENT 2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Dec 6, 1995 | K941558 | MAYFIELD CHILD DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Jan 7, 1994 | K934289 | MAYFIELD RADIOLUCENT SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Sep 28, 1993 | K932860 | MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Sep 28, 1993 | K932807 | MAYFIELD* A-2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. | HBL |
| Feb 12, 1993 | K923789 | MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. | HBL |
| Sep 19, 1991 | K912005 | CODMAN SKULL PINS (ADULT & CHILD), REUSABLE Codman & Shurtleff, Inc. | HBL |
| Sep 10, 1991 | K911723 | CODMAN DISPOSABLE SKULL PINS Codman & Shurtleff, Inc. | HBL |
| Sep 6, 1991 | K913170 | CODMAN SKULL CLAMP Codman & Shurtleff, Inc. | HBL |
| Aug 26, 1991 | K911772 | GARDNER PINS (ADULT & CHILD) Codman & Shurtleff, Inc. | HBL |
| Jul 31, 1991 | K912011 | CODMAN SKULL CLAMP Codman & Shurtleff, Inc. | HBL |
| Sep 4, 1990 | K901393 | MAINZ HEAD FIXATION BY PERNECZKY Zeppelin GmbH, DE | HBL |
| Aug 29, 1989 | K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM Medical Equipment Development Co., Inc. | HBL |
| Feb 4, 1988 | K874298 | MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME Engineered Orthopedic Technologies, Inc. | HBL |
| Sep 28, 1982 | K821772 | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR Downs Surgical , Ltd. | HBL |
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