Panels › Obstetrics/Gynecology › Product code HIB · Class 2
Speculum, Vaginal, Nonmetal
Regulation 884.4530
1510(k)s in 12 months (72 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in HIB
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 1 | 4 |
| Welch Allyn, Inc. | 3 | 1 |
| C.I.S.A. Import Export C/O Larson and Taylor | 3 | 0 |
| Sol Weiss MD, Inc. | 3 | 0 |
| Exitec, Inc. | 2 | 0 |
| Femspec LLC | 2 | 0 |
| Martin Medical | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| Adept-Med Intl., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2026 | K252208 | JFord Speculum Sleeve Ford Medtech, LLC | HIB |
| Apr 28, 2014 | K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM Proa Medical, Inc. | HIB |
| Jan 17, 2014 | K132668 | IOB DISPOSABLE SPECULUM Iob Medical, Inc. | HIB |
| Aug 6, 2013 | K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM Clearspec, LLC | HIB |
| Mar 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL Welch Allyn, Inc. | HIB |
| Sep 15, 2011 | K110766 | KOLPLUX SYSTEM Kolplast CI Ltda | HIB |
| Feb 16, 2010 | K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM Kunshan Deyi Plastic Co., Ltd. | HIB |
| Sep 9, 2009 | K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM Obp Corporation | HIB |
| Feb 8, 2008 | K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM Medline Industries, Inc. | HIB |
| Jan 22, 2008 | K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM Depalt, Inc. | HIB |
| May 18, 2007 | K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM Welch Allyn, Inc. | HIB |
| Sep 19, 2006 | K061339 | HIERSPEC SPECULUM Medical Products Div. | HIB |
| May 4, 2006 | K060129 | IGS VAGINAL SPECULUM Innovative Gynecological Solutions, LLC | HIB |
| Apr 6, 2006 | K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM Gynova, LLC | HIB |
| Feb 2, 2006 | K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I Femspec LLC | HIB |
| Dec 15, 2005 | K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM Zhejiang Yusheng Medical Instrument Co. , Ltd., CN | HIB |
| Nov 9, 2005 | K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE Dynarex Corp. | HIB |
| Jul 11, 2005 | K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM Zhejiang Gongdong Medical Plastic Factory, CN | HIB |
| Dec 23, 2004 | K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM Femspec LLC | HIB |
| Nov 30, 2004 | K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 Panatrex, Inc. | HIB |
| Jun 22, 2004 | K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM Advanced Urological Developments | HIB |
| Aug 27, 2003 | K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM Kentron Health Care, Inc. | HIB |
| Jun 9, 2003 | K030761 | KAISHOU VAGINAL SPECULUM Jiangsu Kaishou Medical Apparatus Co., Ltd., CN | HIB |
| Nov 4, 2002 | K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L Medical Action Industries, Inc. | HIB |
| Jul 16, 2002 | K021849 | TAGG DISPOSABLE VAGINAL SPECULUM Tagg Industries | HIB |
| Jul 12, 2002 | K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL Cypress Medical Products, Ltd. | HIB |
| Jun 19, 2002 | K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM Itl Corporation Pty, Ltd., AU | HIB |
| Jun 19, 2002 | K020959 | GLO-SPEC I, II AND III Sol Weiss MD, Inc. | HIB |
| May 15, 2002 | K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE Dukal Corp. | HIB |
| Mar 1, 2002 | K012535 | DRG DISPOSABLE VAGINAL SPECULUM Doctor'S Research Group, Inc. | HIB |
| Jan 17, 2002 | K013835 | GLOBAL HEALTHCARE VAGINAL SPECULUM Dynascend Consulting Int'L, LLC | HIB |
| Dec 21, 2001 | K013817 | GLO-SPEC Sol Weiss MD, Inc. | HIB |
| Oct 26, 2001 | K012859 | NU-SPEC D Sol Weiss MD, Inc. | HIB |
| Feb 21, 2001 | K002912 | VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 Sterinc | HIB |
| Feb 9, 2001 | K003540 | (DISPOSABLE) VAGINAL SPECULUM Feminica, Inc., CA | HIB |
| Apr 21, 2000 | K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM Prism Enterprises, Inc. | HIB |
| Apr 4, 2000 | K000414 | MEDISUL DISPOSABLE VAGINAL SPECULUM Marketing Perspectives | HIB |
| Sep 29, 1999 | K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM Wallach Surgical Devices, Inc. | HIB |
| Sep 1, 1999 | K991963 | PATTON SPECULUM Patton Medical Corp. | HIB |
| Jul 19, 1999 | K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 Ri Mos. S.R.L. | HIB |
| Dec 23, 1998 | K984211 | MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 Medscand AB, SE | HIB |
| Dec 23, 1998 | K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM Vitalcare Group, Inc. | HIB |
| Dec 19, 1997 | K973853 | KOLPLAST VAGINAL SPECULUM Kolplast Comercial E Industrial Ltda | HIB |
| Dec 12, 1997 | K974228 | HOSPITAL'S SPEC Gps | HIB |
| Sep 26, 1997 | K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS Playtex Products, Inc. | HIB |
| Jun 13, 1997 | K925501 | NYLON COATED SPECULA Zinnanti Surgical Instruments, Inc. | HIB |
| Oct 4, 1996 | K963377 | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC North Eos Industries, Inc., TW | HIB |
| Dec 11, 1995 | K951898 | VERSA-VU CooperSurgical, Inc. | HIB |
| May 11, 1995 | K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM Amsino Intl., Inc. | HIB |
| Aug 2, 1994 | K941272 | KLEENSPEC Welch Allyn, Inc. | HIB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.