FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K040817 |
ADVANCED UROLOGICAL DEVELOPMENTS |
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM |
06/22/2004 |
K130046 |
CLEARSPEC LLC |
CLEARSPEC SINGLE USE VAGINAL SPECULUM |
08/06/2013 |
K021676 |
CYPRESS MEDICAL PRODUCTS, LTD. |
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL |
07/12/2002 |
K072762 |
DEPALT INC. |
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM |
01/22/2008 |
K012535 |
DOCTOR'S RESEARCH GROUP, INC. |
DRG DISPOSABLE VAGINAL SPECULUM |
03/01/2002 |
K020726 |
DUKAL CORP. |
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE |
05/15/2002 |
K052314 |
DYNAREX CORP. |
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE |
11/09/2005 |
K013835 |
DYNASCEND CONSULTING INT'L LLC. |
GLOBAL HEALTHCARE VAGINAL SPECULUM |
01/17/2002 |
K003540 |
FEMINICA, INC. |
(DISPOSABLE) VAGINAL SPECULUM |
02/09/2001 |
K052192 |
FEMSPEC L.L.C. |
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I |
02/02/2006 |
K041757 |
FEMSPEC L.L.C. |
FEMSPEC DISPOSABLE VAGINAL SPECULUM |
12/23/2004 |
K974228 |
GPS |
HOSPITAL'S SPEC |
12/12/1997 |
K052420 |
GYNOVA, LLC |
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM |
04/06/2006 |
K060129 |
INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC |
IGS VAGINAL SPECULUM |
05/04/2006 |
K132668 |
IOB MEDICAL INC |
IOB DISPOSABLE SPECULUM |
01/17/2014 |
K021017 |
ITL CORPORATION, PTY LTD. |
LEESPEC DISPOSABLE VAGINAL SPECULUM |
06/19/2002 |
K030761 |
JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD |
KAISHOU VAGINAL SPECULUM |
06/09/2003 |
K030693 |
KENTRON HEALTH CARE, INC. |
KENTEX DISPOSABLE VAGINAL SPECULUM |
08/27/2003 |
K110766 |
KOLPLAST CI LTDA |
KOLPLUX SYSTEM |
09/15/2011 |
K973853 |
KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
KOLPLAST VAGINAL SPECULUM |
12/19/1997 |
K092870 |
KUNSHAN DEYI PLASTIC CO., LTD. |
NON-STERILE DISPOSABLE VAGINAL SPECULUM |
02/16/2010 |
K000414 |
MARKETING PERSPECTIVES |
MEDISUL DISPOSABLE VAGINAL SPECULUM |
04/04/2000 |
K022948 |
MEDICAL ACTION INDUSTRIES, INC. |
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L |
11/04/2002 |
K061339 |
MEDICAL PRODUCTS DIV. |
HIERSPEC SPECULUM |
09/19/2006 |
K072942 |
MEDLINE INDUSTRIES, INC. |
MEDLINE DISPOSABLE VAGINAL SPECULUM |
02/08/2008 |
K984211 |
MEDSCAND AB |
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 |
12/23/1998 |
K963377 |
NORTH EOS INDUSTRIES, INC. |
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC |
10/04/1996 |
K091937 |
OBP CORPORATION |
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM |
09/09/2009 |
K042950 |
PANATREX, INC. |
VAG O SPECULUM, MODELS VS1, VM1, VL1 |
11/30/2004 |
K991963 |
PATTON MEDICAL CORP. |
PATTON SPECULUM |
09/01/1999 |
K971979 |
PLAYTEX PRODUCTS, INC. |
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS |
09/26/1997 |
K000444 |
PRISM ENTERPRISES, INC. |
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM |
04/21/2000 |
K133857 |
PROA MEDICAL, INC. |
BRELLA-SPEC(TM) VAGINAL SPECULUM |
04/28/2014 |
K991827 |
RI MOS. S.R.L. |
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 |
07/19/1999 |
K013817 |
SOL WEISS MD INC |
GLO-SPEC |
12/21/2001 |
K020959 |
SOL WEISS MD INC |
GLO-SPEC I, II AND III |
06/19/2002 |
K012859 |
SOL WEISS MD INC |
NU-SPEC D |
10/26/2001 |
K002912 |
STERINC |
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 |
02/21/2001 |
K021849 |
TAGG INDUSTRIES |
TAGG DISPOSABLE VAGINAL SPECULUM |
07/16/2002 |
K983716 |
VITALCARE GROUP, INC. |
VITALCARE DISPOSABLE VAGINAL SPECULUM |
12/23/1998 |
K992736 |
WALLACH SURGICAL DEVICES, INC. |
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM |
09/29/1999 |
K070964 |
WELCH ALLYN, INC. |
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM |
05/18/2007 |
K120743 |
WELCH ALLYN, INC. |
SPECULUM, VAGINAL, NONMETAL |
03/23/2012 |
K050887 |
ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
GONGDONG DISPOSABLE VAGINAL SPECULUM |
07/11/2005 |
K052912 |
ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. |
YUSHENG DISPOSABLE VAGINAL SPECULUM |
12/15/2005 |
K925501 |
ZINNANTI SURGICAL INSTRUMENTS, INC. |
NYLON COATED SPECULA |
06/13/1997 |