Speculum, Vaginal, Metal
Obstetrics/Gynecology · 21 CFR 884.4520
Recent MDR events
44 adverse event reports on file
- LEEP INSULATED VAGINAL SPECULUMMar 31, 2026MalfunctionCoopersurgical, Inc.MW5186196
- VAGINAL SPECULUMDec 1, 2025InjuryUnkMW5179589
- GRAVE SPECIAL VAGINAL SPECULUMApr 18, 2024MalfunctionBauer Und Haeselbarth-chirurg Gmbh3002806450-2024-00001
- GRAVE SPECIAL VAGINAL SPECULUMApr 18, 2024MalfunctionBauer Und Haeselbarth-chirurg Gmbh3002806450-2024-00002
- VAGINAL SPECULUMApr 5, 2024OtherTrinity Sterile, Inc.MW5153592
- VAGINAL SPECULUMApr 5, 2024OtherTrinity Sterile, Inc.MW5153593
- SPECULUMJun 14, 2023InjuryUnkMW5118416
- GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8INFeb 23, 2023MalfunctionCarefusion, Inc1423507-2023-00086
- LEEP GRAVES SPEC MEDNov 11, 2022MalfunctionCoopersurgical, Inc.1216677-2022-00297
- LEEP GRAVES SPEC LARGENov 11, 2022MalfunctionCoopersurgical, Inc.1216677-2022-00296
Event type breakdown
Recalls
3 recall events for this product code
- Sklar InstrumentsOpen, ClassifiedJan 16, 2025
ECONO STERILE medical procedure kits labeled as:
Reports of various packaging issues that may result in a breach of the sterile barrier.
Z-0944-2025 · View FDA record ↗ - Carefusion 2200 IncOpen, ClassifiedApr 21, 2023
(1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blade, 4 x 1 3/8" (10.2 X 3.5cm); and (2) Carefusion V. Mueller Pederson Vaginal Specul
A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products.
Z-1421-2023 · View FDA record ↗ - Centurion Medical Products CorporationTerminatedUnknown
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It
Potential for sterile packaging to be compromised
Z-2161-2019 · View FDA record ↗
Registered firms
228 firms currently registered for this product code
Kls-martin L.p.
Jacksonville, FL, US
Biopsy Fine Cut Instruments
Sialkot Punjab, PK
Madina Surgical Works
Sialkot Punjab, PK
Sklar Corporation
Malvern, PA, US
Stingray Surgical Products
Boca Raton, FL, US
Itm Industria De Tecnologias Medicas Ltda
CANOAS Rio Grande do Sul, BR
Gynex Corporation
North Richland Hills, TX, US
Jay-med
SIALKOT Punjab, PK
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Fetzer Surgical, Llc
Scottsdale, AZ, US
Baeramed Instrumente Gmbh
SCHWENNINGEN Baden-Wurttemberg, DE
Premier Dental Products Co.
PLYMOUTH MEETING, PA, US
Trinity Sterile, Inc.
SALISBURY, MD, US
Commic Surgico
SIALKOT Punjab, PK
Eltek Instruments (pvt.) Ltd.
Sialkot Punjab, PK
Weldon Instruments
Sialkot Punjab, PK
Swann-morton(services) Limited
Owlerton Green Sheffield, GB
J & J Instruments, Llc
Stratford, CT, US
Solatch Sons
SIALKOT Punjab, PK
Hazel Enterprises
Sialkot Punjab, PK
Customed, Inc.
Fajardo, PR, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Diligent Medical Services
SIALKOT Punjab, PK
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Swengg Co
Sialkot Punjab, PK
510(k) clearances
11 clearances for this product code
- Thomasville Medical Assoc.Feb 28, 1994
K926429 · VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT
- Gynescope Corp.Jun 7, 1990
K902019 · MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
- Zinnanti Surgical Instruments, Inc.Mar 22, 1989
K891041 · MIYA SPECULUM
- Zinnanti Surgical Instruments, Inc.Mar 17, 1989
K891044 · LASER SPECULA
- Kinetic Medical ProductsFeb 13, 1989
K890375 · VAGINAL SPECULUM
- Franklin Medical USA, Inc.Nov 24, 1986
K862478 · HAYES VAGINAL SHIELD
- Downs Surgical , Ltd.Oct 29, 1985
K853640 · WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL
- ArtiberiaMay 22, 1985
K851799 · 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA