FDA 510(k) Applications Submitted by David Lin
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071330 |
05/11/2007 |
GALTSTICK INTRODUCER SYSTEM |
GALT MEDICAL CORP. |
| K021990 |
06/18/2002 |
GALT MEDICAL GUIDEWIRE |
GALT MEDICAL CORP. |
| K031916 |
06/20/2003 |
GALT MEDICAL GUIDEWIRE |
GALT MEDICAL CORP. |
| K033542 |
11/10/2003 |
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE |
GALT MEDICAL CORP. |
| K043525 |
12/21/2004 |
CATHETER INTRODUCER |
GALT MEDICAL CORP. |
| DEN220065 |
09/29/2022 |
Pill Sense System |
EnteraSense Ltd. |
| K142027 |
07/25/2014 |
888 WNLE POWERED WHEELCHAIR |
PIHSIANG MACHINERY MFG. CO., LTD. |
| K023394 |
10/09/2002 |
UNISIGHT SYSTEM WITH UNIGATE |
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) |
| K243272 |
10/16/2024 |
LOCATOR Angled Abutment |
Zest Anchors, LLC |
| K233587 |
11/08/2023 |
LOCATOR Angled Abutment (Various) |
Zest Anchors, LLC |
| K021258 |
04/19/2002 |
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER |
GERM TERMINATOR CORPORATION |
| K000728 |
03/06/2000 |
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE |
MEDTRONIC XOMED |
| K990793 |
03/10/1999 |
ACCUGUIDE MUSCLE INJECTION MONITOR |
MEDTRONIC XOMED |
| K970910 |
03/12/1997 |
XOMED SILICONE BLOCK/STRIP |
XOMED, INC. |
| K971124 |
03/27/1997 |
TM MICRO-CATHETERS |
XOMED, INC. |
| K961873 |
05/15/1996 |
ACTIVENT ANTIMICROBIAL VENTILATION TUBES |
XOMED, INC. |
| K972453 |
06/30/1997 |
XPS STRAIGHTSHOT MICRORESECTOR |
XOMED, INC. |
| K982595 |
07/27/1998 |
NIM4 |
XOMED, INC. |
| K963246 |
08/19/1996 |
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT |
MEDTRONIC XOMED |
| K992855 |
08/24/1999 |
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT |
XOMED, INC. |
| K983224 |
09/14/1998 |
XPS DRILL SYSTEM |
XOMED, INC. |
| K963727 |
09/16/1996 |
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER |
MEDTRONIC XOMED |
| K973499 |
09/16/1997 |
XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM |
XOMED, INC. |
| K002897 |
09/18/2000 |
TITANIUM MIDDLE EAR PROSTHESES |
XOMED, INC. |
| K964484 |
11/07/1996 |
KARTUSH TM PATCHER |
XOMED, INC. |
| K984363 |
12/07/1998 |
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM |
XOMED, INC. |
| K964909 |
12/09/1996 |
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS |
XOMED, INC. |
| K965233 |
12/31/1996 |
SHARPSITE AC |
XOMED, INC. |
| K960966 |
03/11/1996 |
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 |
SUNBEAM-OSTER HOUSEHOLD PRODUCTS |
| K012914 |
08/30/2001 |
SONICWAVE SONIC PLAQUE REMOVER |
HOMEDICS, INC. |
| K120412 |
02/10/2012 |
3M SPOTON TEMPERATURE MONITORING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K060865 |
03/30/2006 |
BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 |
ARIZANT HEALTHCARE INC. |
| K060939 |
04/06/2006 |
RANGER IRRIGATION FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K041686 |
06/22/2004 |
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM |
ARIZANT HEALTHCARE INC. |
| K082217 |
08/06/2008 |
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
| K053645 |
12/30/2005 |
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS |
ARIZANT HEALTHCARE INC. |
| K962532 |
06/28/1996 |
RODENSTOCK SLITLAMP (MODEL 5000 & 4000) |
EXPERTECH ASSOC., INC. |
| K973220 |
08/27/1997 |
RODENSTOCK LASER SLITLAMP |
G. RODENSTOCK INSTRUMENTE GMBH |
| K960853 |
03/01/1996 |
ACE SYSTEM |
XOMED, INC. |
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