Speculum, Vaginal, Nonmetal

FDA product code HIB · 70 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4530
Review panel: OB
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-08-19 – 2026-03-06

HIB 2026-03-06

JFord Speculum Sleeve™

Applicant Ford Medtech, LLC

K number K252208

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HIB 2013-08-06

CLEARSPEC SINGLE USE VAGINAL SPECULUM

Applicant Clearspec, LLC

K number K130046

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HIB 2012-03-23

SPECULUM, VAGINAL, NONMETAL

Applicant Welch Allyn, Inc.

K number K120743

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HIB 2011-09-15

KOLPLUX SYSTEM

Applicant Kolplast CI Ltda

K number K110766

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HIB 2010-02-16

NON-STERILE DISPOSABLE VAGINAL SPECULUM

Applicant Kunshan Deyi Plastic Co., Ltd.

K number K092870

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HIB 2009-09-09

OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM

Applicant Obp Corporation

K number K091937

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HIB 2008-02-08

MEDLINE DISPOSABLE VAGINAL SPECULUM

Applicant Medline Industries, Inc.

K number K072942

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HIB 2008-01-22

DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM

Applicant Depalt, Inc.

K number K072762

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HIB 2007-05-18

KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM

Applicant Welch Allyn, Inc.

K number K070964

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HIB 2006-09-19

HIERSPEC SPECULUM

Applicant Medical Products Div.

K number K061339

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HIB 2006-05-04

IGS VAGINAL SPECULUM

Applicant Innovative Gynecological Solutions, LLC

K number K060129

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HIB 2006-04-06

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM

Applicant Gynova, LLC

K number K052420

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HIB 2006-02-02

FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I

Applicant Femspec LLC

K number K052192

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HIB 2005-12-15

YUSHENG DISPOSABLE VAGINAL SPECULUM

Applicant Zhejiang Yusheng Medical Instrument Co. , Ltd.

K number K052912

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HIB 2005-11-09

DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE

Applicant Dynarex Corp.

K number K052314

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HIB 2005-07-11

GONGDONG DISPOSABLE VAGINAL SPECULUM

Applicant Zhejiang Gongdong Medical Plastic Factory

K number K050887

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HIB 2004-12-23

FEMSPEC DISPOSABLE VAGINAL SPECULUM

Applicant Femspec LLC

K number K041757

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HIB 2004-11-30

VAG O SPECULUM, MODELS VS1, VM1, VL1

Applicant Panatrex, Inc.

K number K042950

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HIB 2004-06-22

POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM

Applicant Advanced Urological Developments

K number K040817

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HIB 2003-08-27

KENTEX DISPOSABLE VAGINAL SPECULUM

Applicant Kentron Health Care, Inc.

K number K030693

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HIB 2003-06-09

KAISHOU VAGINAL SPECULUM

Applicant Jiangsu Kaishou Medical Apparatus Co., Ltd.

K number K030761

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HIB 2002-11-04

VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L

Applicant Medical Action Industries, Inc.

K number K022948

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HIB 2002-07-16

TAGG DISPOSABLE VAGINAL SPECULUM

Applicant Tagg Industries

K number K021849

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HIB 2002-07-12

CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL

Applicant Cypress Medical Products, Ltd.

K number K021676

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HIB 2002-06-19

LEESPEC DISPOSABLE VAGINAL SPECULUM

Applicant Itl Corporation Pty, Ltd.

K number K021017

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HIB 2002-06-19

GLO-SPEC I, II AND III

Applicant Sol Weiss MD, Inc.

K number K020959

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HIB 2002-05-15

DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE

Applicant Dukal Corp.

K number K020726

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HIB 2002-03-01

DRG DISPOSABLE VAGINAL SPECULUM

Applicant Doctor'S Research Group, Inc.

K number K012535

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HIB 2002-01-17

GLOBAL HEALTHCARE VAGINAL SPECULUM

Applicant Dynascend Consulting Int'L, LLC

K number K013835

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HIB 2001-12-21

GLO-SPEC

Applicant Sol Weiss MD, Inc.

K number K013817

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HIB 2001-10-26

NU-SPEC D

Applicant Sol Weiss MD, Inc.

K number K012859

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HIB 2001-02-21

VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073

Applicant Sterinc

K number K002912

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HIB 2001-02-09

(DISPOSABLE) VAGINAL SPECULUM

Applicant Feminica, Inc.

K number K003540

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HIB 2000-04-21

MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM

Applicant Prism Enterprises, Inc.

K number K000444

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HIB 2000-04-04

MEDISUL DISPOSABLE VAGINAL SPECULUM

Applicant Marketing Perspectives

K number K000414

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HIB 1999-09-29

WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM

Applicant Wallach Surgical Devices, Inc.

K number K992736

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HIB 1999-09-01

PATTON SPECULUM

Applicant Patton Medical Corp.

K number K991963

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HIB 1999-07-19

GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043

Applicant Ri Mos. S.R.L.

K number K991827

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HIB 1998-12-23

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

Applicant Medscand AB

K number K984211

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HIB 1998-12-23

VITALCARE DISPOSABLE VAGINAL SPECULUM

Applicant Vitalcare Group, Inc.

K number K983716

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HIB 1997-12-19

KOLPLAST VAGINAL SPECULUM

Applicant Kolplast Comercial E Industrial Ltda

K number K973853

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HIB 1997-12-12

HOSPITAL'S SPEC

Applicant Gps

K number K974228

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HIB 1997-09-26

PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS

Applicant Playtex Products, Inc.

K number K971979

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HIB 1997-06-13

NYLON COATED SPECULA

Applicant Zinnanti Surgical Instruments, Inc.

K number K925501

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HIB 1996-10-04

EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC

Applicant North Eos Industries, Inc.

K number K963377

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HIB 1995-12-11

VERSA-VU

Applicant CooperSurgical, Inc.

K number K951898

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HIB 1995-05-11

AMSINO DISPOSABLE VIGINAL SPECULUM

Applicant Amsino Intl., Inc.

K number K951528

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HIB 1994-08-02

KLEENSPEC

Applicant Welch Allyn, Inc.

K number K941272

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HIB 1994-06-30

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV

Applicant Cabot Medical Corp.

K number K930954

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HIB 1994-04-21

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION

Applicant Olsen Electrosurgical, Inc.

K number K922154

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HIB 1994-03-25

GRAVESPEC

Applicant Adept-Med Intl., Inc.

K number K935636

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HIB 1994-03-07

SPECULUM

Applicant Bioteque America, Inc.

K number K933521

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HIB 1994-02-25

DISPOSABLE PLASTIC VAGINAL SPECULA

Applicant Thomasville Medical Assoc.

K number K926536

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HIB 1992-10-19

HSG TRAY

Applicant Unimar, Inc.

K number K920803

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HIB 1990-09-19

DISPOSABLE PLASTIC VAGINAL SPECULUM

Applicant Dawnex Industries, Inc.

K number K903080

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HIB 1990-09-12

PHYSICIAN'S CHOICE

Applicant Advance Medical Device, Inc.

K number K903744

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HIB 1989-10-12

DISPOSABLE PLASTIC VAGINAL SPECULA

Applicant Zinnanti Surgical Instruments, Inc.

K number K894957

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HIB 1989-10-05

GYNECOLOGIC EXAMINATION KIT

Applicant A & A Medical, Inc.

K number K894489

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HIB 1988-12-20

AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4

Applicant C.I.S.A. Import Export C/O Larson and Taylor

K number K880588

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HIB 1988-12-20

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3

Applicant C.I.S.A. Import Export C/O Larson and Taylor

K number K880587

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HIB 1988-12-20

AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2

Applicant C.I.S.A. Import Export C/O Larson and Taylor

K number K880586

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HIB 1988-09-15

EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM

Applicant Buckman Co., Inc.

K number K882605

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HIB 1986-09-02

MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM

Applicant Martin Medical

K number K863275

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HIB 1986-09-02

MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM

Applicant Martin Medical

K number K863274

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HIB 1984-08-17

HOSPITAL'S-SPEC

Applicant Merex Co.

K number K842014

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HIB 1984-07-31

VAGINAL SPECULUM - DISPOSABLE

Applicant Galenica Enterprises, Inc.

K number K841909

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HIB 1984-07-13

KIDD VAGINAL SPECULUM

Applicant Paul H. Schneider Ent.

K number K841867

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HIB 1983-04-27

GENT-L-SPEC DISPOS. VAGINAL SPECULUM

Applicant Geneva Laboratories, Inc.

K number K830725

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HIB 1982-11-08

DIA-SPEC

Applicant Exitec, Inc.

K number K822086

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HIB 1982-08-19

PRO-SPEC

Applicant Exitec, Inc.

K number K822084

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