FDA 510(k) Applications Submitted by Janice Haselton
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110038 |
01/06/2011 |
TRUCLEAR MORCELLATOR SYSTEM |
SMITH & NEPHEW, INC. |
| K060123 |
01/18/2006 |
LEVELERT II FLUID LEVEL SENSOR |
SMITH & NEPHEW, INC. |
| K030196 |
01/21/2003 |
DYONICS POWER CONTROL UNIT |
SMITH & NEPHEW, INC. |
| K050209 |
01/28/2005 |
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM |
SMITH & NEPHEW, INC. |
| K070266 |
01/29/2007 |
560 HIGH DEFINITION CAMERA SYSTEM |
SMITH & NEPHEW, INC. |
| K190367 |
02/15/2019 |
Smith & Nephew Tablet Application |
Smith & Nephew |
| K031379 |
05/01/2003 |
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 |
SMITH & NEPHEW, INC. |
| K201198 |
05/04/2020 |
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable |
Smith & Nephew |
| K051326 |
05/20/2005 |
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM |
SMITH & NEPHEW, INC. |
| K031605 |
05/22/2003 |
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY |
SMITH & NEPHEW, INC. |
| K081511 |
05/29/2008 |
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S |
SMITH & NEPHEW, INC. |
| K031787 |
06/10/2003 |
SMITH & NEPHEW IUR MORCELLATION SYSTEM |
SMITH & NEPHEW, INC. |
| K111843 |
06/29/2011 |
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
| K121904 |
06/29/2012 |
GYNECOLOGY STERILIZATION TRAY |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| K041774 |
07/01/2004 |
IUR RECIPROCATING MORCELLATOR MODEL # 7210517 |
SMITH & NEPHEW, INC. |
| K112134 |
07/27/2011 |
TRUCLEAR OPERATIVE HYSTEROSCOPE |
SMITH & NEPHEW, INC. |
| K012724 |
08/14/2001 |
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 |
SMITH & NEPHEW, INC. |
| K072675 |
09/21/2007 |
SMITH & NEPHEW ARTHROSCOPE |
SMITH & NEPHEW, INC. |
| K192876 |
10/08/2019 |
INTELLIO Tablet Application |
Smith & Nephew |
| K103389 |
11/18/2010 |
TRUCLEAR INCISOR PLUS BLADE 2.9 |
SMITH & NEPHEW, INC. |
| K013870 |
11/21/2001 |
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 |
SMITH & NEPHEW, INC. |
| K003710 |
12/01/2000 |
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905 |
SMITH & NEPHEW, INC. |
| K994084 |
12/03/1999 |
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES |
SMITH & NEPHEW, INC. |
| K153606 |
12/17/2015 |
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application |
SMITH & NEPHEW |
| K033981 |
12/23/2003 |
SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 |
SMITH & NEPHEW, INC. |
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