FDA 510(k) Searchable Database - Search 175,000+ Clearances

Cleared Sep 30, 2003

DURAGEN PLUS DURAL GRAFT MATRIX

K032693 · GXQ

Integra Lifesciences Corp.

Neurology · 28d

Cleared Sep 25, 2003

SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT

K032497 · HCG

Micro Therapeutics, Inc.

Neurology · 43d

Cleared Sep 23, 2003

TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS...

K032553 · HCG

Cordis Neurovascular, Inc.

Neurology · 35d

Cleared Sep 23, 2003

CONTOUR SE MICROSPHERES (SYRINGE)

K032707 · HCG

Boston Scientific Corp

Neurology · 21d

Cleared Sep 23, 2003

MYOSYSTEM WITH CUSTOMIZING

K032833 · GXY

Otto Bock Healthcare LP

Neurology · 12d

Cleared Sep 22, 2003

ULTRA-DRIVE 3

K031280 · JDX

Biomet, Inc.

Neurology · 153d

Cleared Sep 16, 2003

MODIFICATION TO CONTOUR SE MICROSPHERES

K032542 · HCG

Boston Scientific Corp

Neurology · 29d

Cleared Sep 15, 2003

ACUMEN SURGICAL NAVIGATION SYSTEM

K031337 · HAW

Biomet, Inc.

Neurology · 140d

Cleared Sep 15, 2003

RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

K032054 · HAW

Radionics, A Division of Tyco...

Neurology · 75d

Cleared Sep 12, 2003

THERMOSKIN CONDUCTIVE PADS

K030564 · GXY

United Pacific, Inc.

Neurology · 203d

Cleared Sep 12, 2003

E275

K032653 · GZJ

Micro Current Technology, Inc.

Neurology · 15d

Cleared Sep 11, 2003

RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE...

K032561 · GZB

Medtronic Vascular

Neurology · 22d

Cleared Sep 08, 2003

DURASIS DURAL SUBSTITUTE

K031850 · GXQ

Cook Biotech, Inc.

Neurology · 84d

Cleared Aug 29, 2003

MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

K031694 · OLW

Aspect Medical Systems, Inc.

Neurology · 88d

Cleared Aug 25, 2003

NEUROTECH BAXOLVE TYPE 294

K023913 · GZJ

Bio-Medical Research, Ltd.

Neurology · 273d

Cleared Aug 21, 2003

NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

K031885 · HBL

Image-Guided Neurologics, Inc.

Neurology · 64d

Cleared Aug 20, 2003

SAPPHIRE DETACHABLE FIBER COILS

K031852 · HCG

Micro Therapeutics, Inc.

Neurology · 65d

Cleared Aug 20, 2003

AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP

K032198 · HCH

Aesculap, Inc.

Neurology · 33d

Cleared Aug 12, 2003

CI TKR/UKR

K031770 · HAW

Brainlab AG

Neurology · 64d

Cleared Aug 08, 2003

VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1

K024359 · MYU

Vista Scientific, LLC

Neurology · 221d

Cleared Aug 08, 2003

SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)

K031654 · GXR

Synthes (Usa)

Neurology · 72d

Cleared Aug 08, 2003

HANDMASTER

K031900 · GZI

Ness-Neuromuscular Electrical...

Neurology · 50d

Cleared Aug 01, 2003

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

K014241 · NCX

Alsius Corp.

Neurology · 583d

Cleared Aug 01, 2003

BALL RECORDING ELECTRODE/STIMULATION PROBE

K030517 · GZK

Viasys Healthcare, Inc.

Neurology · 163d