FDA 510(k) Applications Submitted by CAROLANN KOTULA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980024 |
01/05/1998 |
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER |
SHINING WORLD HEALTH CARE CO., LTD. |
| K040052 |
01/12/2004 |
FINE SURGICAL CIRCUMCISION CLAMP |
FINE SURGICAL INSTRUMENT CORP. |
| K960194 |
01/16/1996 |
MYELOTEC MYELOSCOPE |
MYELOTEC, INC. |
| K040116 |
01/20/2004 |
HAWK INTRAORAL CAMERA AND ACCESSORIES |
DXM CO., LTD. |
| K060171 |
01/23/2006 |
CLEANSE S+ ULTRASONIC SCALER |
DMETEC CO., LTD. |
| K040282 |
02/06/2004 |
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
| K970937 |
03/13/1997 |
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM) |
MIST, INC. |
| K961227 |
03/28/1996 |
JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY |
J.J. SKINNER, INC. |
| K971150 |
03/28/1997 |
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE |
MIST, INC. |
| K971317 |
04/09/1997 |
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS |
NATIONAL HEALTHCARE MFG. CORP. |
| K021186 |
04/15/2002 |
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG, |
CONDOMI ERFERT PRODOKTIONSGESELLSCHAFT MBH |
| K971465 |
04/22/1997 |
NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS |
NATIONAL HEALTHCARE MFG. CORP. |
| K041048 |
04/22/2004 |
POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
| K972013 |
05/30/1997 |
NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS |
NATIONAL HEALTHCARE MFG. CORP. |
| K972117 |
06/05/1997 |
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW |
MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
| K041535 |
06/08/2004 |
LSC LIFESTAND COMPACT |
LIFESTAND |
| K051571 |
06/14/2005 |
SKYLIGHT LED CURING LIGHT |
DMETEC CO., LTD. |
| K001896 |
06/21/2000 |
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC |
SUZUKEN CO., LTD. |
| K051686 |
06/23/2005 |
CARDIOMEM CM 3000-12 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
| K962596 |
07/02/1996 |
CUSTOMED BLOOD EXTRACTION KIT |
CUSTOMED, INC. |
| K962807 |
07/18/1996 |
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES |
AMERICAN SURGICAL SPONGES |
| K022809 |
08/23/2002 |
EZ SPLINT & EZ SPLINT PM |
POWER PRODUCTS, INC.-SPLINTEK |
| K954284 |
08/30/1995 |
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) |
MEDI-PLAST INTL., INC. |
| K042458 |
09/10/2004 |
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM |
A.M. SURGICAL, INC. |
| K062725 |
09/13/2006 |
MAXIFLEX-SEMI FLEX SCOPE |
TECHNOLOGY DELIVERY SYSTEMS, INC. |
| K042703 |
09/30/2004 |
CYBIRD LED CURING LIGHT |
DXM CO., LTD. |
| K042818 |
10/12/2004 |
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037 |
MATSUSHITA ELECTRIC WORKS, LTD. |
| K033403 |
10/24/2003 |
T.S. MEDICAL CIRCUMCISION CLAMP |
T.S. MEDICAL |
| K974082 |
10/29/1997 |
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE |
PERFORMANCE PLUS, INC. |
| K013768 |
11/13/2001 |
POWERED MUSCLE STIMULATOR |
THERATECH, INC. |
| K033790 |
12/04/2003 |
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES |
TECNIMED S.R.L. |
| K974649 |
12/12/1997 |
BIO-POST DENTAL POST SYSTEM |
ADVANCED AEROMEDICAL, INC. |
| K974672 |
12/15/1997 |
MSI SURGICAL DRAPES |
MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
| K033894 |
12/16/2003 |
PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032 |
MATSUSHITA ELECTRIC WORKS, LTD. |
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