FDA 510(k) Applications Submitted by IAN GORDON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070085 |
01/09/2007 |
BALANCE REHABILITATION UNIT (BRU) |
MEDICAA (URUGUAY) S.A. |
| K070296 |
01/31/2007 |
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM |
ACE VISION GROUP |
| K080290 |
02/04/2008 |
XVIEWNET |
AMERICAN RADIOLOGIST NETWORK, INC. |
| K101128 |
04/22/2010 |
BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 |
FILLIGENT LIMITED |
| K091363 |
05/08/2009 |
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER |
AG INDUSTRIES |
| K051255 |
05/16/2005 |
LUMIPHASE-R |
OPUSMED INC. |
| K051371 |
05/26/2005 |
INTERBODY INNOVATIONS CEMENT RESTRICTOR |
INTERBODY INNOVATIONS LLP |
| K061590 |
06/08/2006 |
SMDIE DEVICE INTERFACING SYSTEM |
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT |
| K052087 |
08/02/2005 |
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 |
AG INDUSTRIES |
| K072475 |
09/04/2007 |
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) |
ETAC SVERIGE AB |
| K072569 |
09/12/2007 |
METOXIT CAM-BLANKS |
Metoxit AG |
| K063137 |
10/16/2006 |
PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS-1500/PS-2000 |
PHARMASMART, INC. |
| K052934 |
10/19/2005 |
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
S.O.R. INTERNACIONAL, S.A. |
| K073307 |
11/23/2007 |
MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM |
BIO-TECHNOLOGY USA, INC. |
| K083618 |
12/08/2008 |
PACS SCAN |
PACSGEAR, INC. |
| K050152 |
01/24/2005 |
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE |
DIPPED PRODUCTS (THAILAND) LTD |
| K060416 |
02/17/2006 |
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE |
ULRICH GMBH & CO. KG |
| K051853 |
07/08/2005 |
CARDIOSTREAM SONOAIM |
CARDIOSTREAM, LLC |
| K071908 |
07/10/2007 |
DOCTOR'S LIGHT LED DENTAL CURING LIGHT |
GOOD DOCTORS CO., LTD. |
| K062159 |
07/28/2006 |
RB12 SUCTION RECTAL BIOPSY SYSTEM |
AUS SYSTEMS PTY LTD. |
| K062389 |
08/16/2006 |
Z-BLOCK, MODELS 20/19, 40/19, 55/19 |
FOUNDATION MILLING CENTRE |
| K052245 |
08/17/2005 |
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS |
LAR MFG., LLC. |
| K072947 |
10/18/2007 |
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS |
CLEARSTREAM TECHNOLOGIES, LTD. |
| K053306 |
11/28/2005 |
IVIEW |
ONDEMANDSOFT |
| K073444 |
12/07/2007 |
TRITON MEIDCAL TMED IV-SET |
TRITON MEDICAL, LLC |
| K073446 |
12/07/2007 |
GRIND GUARD |
ARCHTEK, INC. |
| K043367 |
12/08/2004 |
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE |
LACE ELECTRONICA S.R.L. |
| K073581 |
12/20/2007 |
ICI P AND S SERIES IR CAMERAS |
TEXAS INFRARED |
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