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Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

5510(k)s in 12 months (426 all time)
7recalls in 12 months (202 all time)
199recalls that name a 510(k)
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Top companies in HAW

Company510(k)sRecalls
Medtronic Navigation1967
Brainlab599
FHC, Inc.624
Elekta Instrument AB164
Stryker Instruments Division of Stryker Corporation019
Stryker Instruments Div. of Stryker Corporation017
Zimmer Biomet, Inc.016
Image-Guided Neurologics, Inc.150
Surgical Navigation Technologies, Inc.150
Medtronic Surgical Navigation Technologies111
Decided510(k)Device and applicantCode
Mar 7, 1991K901883STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE
Stereotactic Image Systems, Inc.
HAW
Jul 3, 1990K901670GNOMOS STEREOTACTIC DEVICE
Medical Equipment Development Co., Inc.
HAW
May 31, 1990K900200COOK STEREOTAXIC GUIDE
Cook, Inc.
HAW
Nov 7, 1989K894387WESTCO MADAYAG PAB NEEDLE
Western Medical, Ltd.
HAW
Sep 1, 1989K894263CASS SYSTEM
Medical Instrumentation & Diagnostics Corp.(Midco)
HAW
Aug 9, 1988K881132LAITINEN'S TRIGEMINUS STEREOGUIDE
Sandstrom Trade & Technology, Inc., CA
HAW
Aug 1, 1988K881131THE LAITINEN STEREOTACTIC SYSTEM
Sandstrom Trade & Technology, Inc., CA
HAW
Mar 11, 1988K874693OBT STEREOTACTIC SYSTEM
Tipal Instruments , Ltd., CA
HAW
Mar 3, 1988K874833ARC ADAPTER ASSEMBLY
Medical Equipment Development Co., Inc.
HAW
Feb 12, 1988K872877TARGET PROGRAM & EPSON HX-20 COMPUTER
Walter Lorenz Surgical, Inc.
HAW
May 8, 1987K871046COMPASS STEREOTACTIC POSITIONING SYSTEM
Stereotactic Medical Systems, Inc.
HAW
Aug 12, 1986K861629KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES
Downs Surgical , Ltd.
HAW
Jun 18, 1986K862220COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
Stereotactic Medical Systems, Inc.
HAW
Feb 20, 1986K854475GHAJAR INTRAVENTRICULAR CATHETER GUIDE
Sparta Instrument Corp.
HAW
Aug 21, 1985K852662GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY
Neurosurgical Devices, Inc.
HAW
Jul 30, 1985K852477KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
Mayo Clinic
HAW
Jul 26, 1985K851973DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
Diasonics, Inc.
HAW
Jul 1, 1985K851659SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
Medco Products, Co., Inc.
HAW
Dec 29, 1983K833484COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
A. Patil, M.D.
HAW
Jul 12, 1983K830999DAP II BIOPSY GUIDE
Rapid Machine & Tool Corp.
HAW
Jun 15, 1983K831329PMT VAXIOM STEREOTACTIC SYS #FX001
Progress Mankind Technology
HAW
Mar 17, 1983K823424MENISCECTOMY TRAY #9715
Concept, Inc.
HAW
Jan 5, 1983K823675FRONING GUIDANCE SYSTEM #TX-8200
Today'S Machining & Design, Inc.
HAW
Dec 3, 1981K812744LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER
Progress Mankind Technology
HAW
Jun 2, 1981K811452BROWN-ROBERTS-WELLS STEREOTAXIC SYTEM
Trent Wells, Inc.
HAW
Apr 5, 1979K790502DYONICS STEROTOXIC POSITIONER
Dyonics, Inc.
HAW

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