Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

6510(k)s in 12 months (427 all time)

7recalls in 12 months (202 all time)

199recalls that name a 510(k)

Top companies in HAW

Company	510(k)s	Recalls
Medtronic Navigation	19	67
Brainlab	59	9
FHC, Inc.	6	24
Elekta Instrument AB	16	4
Stryker Instruments Division of Stryker Corporation	0	19
Stryker Instruments Div. of Stryker Corporation	0	17
Zimmer Biomet, Inc.	0	16
Image-Guided Neurologics, Inc.	15	0
Surgical Navigation Technologies, Inc.	15	0
Medtronic Surgical Navigation Technologies	11	1

Date	Firm and product	Code	Linked 510(k)
Oct 19, 2004	Stryker Instruments, Instruments Div. Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000. Terminated	HAW	K022365
Dec 17, 2003	Medtronic Surgical Navigation Tech, Inc Fix pins associated with Stealth Station Treatment Guidance Platform Terminated	HAW	K001153 K012937 +2

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