FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K091240 |
ALPHAMED INC. |
ALPHAMED SURGICAL SPEAR, MODEL 70-5000 |
10/23/2009 |
K972693 |
DEROYAL INDUSTRIES, INC. |
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR |
09/30/1997 |
K132796 |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
SUNTOUCH EYE SPEAR |
10/30/2013 |
K990671 |
HURRICANE MEDICAL |
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE |
05/10/1999 |
K974313 |
HYDROFERA, LLC. |
HYDROFERA SURGICAL SPEAR |
03/02/1998 |
K082460 |
LONGTEK SCIENTIFIC CO., LTD. |
CENEFOM PVA SURGICAL SPEAR |
12/15/2008 |
K993883 |
M-PACT CORP. |
M-PACT CORNEAL LIGHT SHIELD |
12/21/1999 |
K971832 |
M-PACT WORLDWIDE MANAGEMENT CORP. |
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK |
07/31/1997 |
K002279 |
MED-LOGICS, INC. |
ML EYE SPEAR, MODEL ML 27 ES |
08/18/2000 |
K011191 |
MEDTRONIC XOMED, INC. |
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES |
06/26/2001 |
K130117 |
NETWORK MEDICAL PRODUCTS, LTD. |
NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS |
10/29/2013 |
K982599 |
OPHTHALMIC SOLUTIONS, LLC. |
THE FREMSTAD RING |
02/16/1999 |
K003842 |
PRESCOTT'S, INC. |
PRESCOTT'S SURGICAL SPEAR |
04/13/2001 |
K964855 |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD |
03/04/1997 |
K012196 |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
ULTRACELL ABSORBENT STICK |
08/24/2001 |
K972633 |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
ULTRACELL SUCTION SPONGE |
12/17/1997 |
K990749 |
X-TECH MEDICAL, LLC. |
SOF-SUCTION FLUID EVACUATION SYSTEM |
04/02/1999 |