Specula, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
21 adverse event reports on file
- BVI EYE SPECULUM (OPEN BLADE), 0.8MMMar 13, 2025MalfunctionBeaver-visitec International, Ltd3002808441-2025-00002
- AIM-ARM RADIOLUCJun 20, 2022MalfunctionWrights Lane Synthes Usa Products Llc2939274-2022-02293
- RHEIN, CONNOR WAND STRAIGHTOct 29, 2021Malfunction12719214
- INVITRIA OPHTHALMIC SPECULUMJul 1, 2019InjuryMedical Workshop B.v.MW5087789
- ALFONZO EYE SPECULUM NEWBORNJan 8, 2010MalfunctionMsi Precision Specialty Instruments1586374
- TERRY-SCHANZLIN ASTIGMATOMEOct 18, 2007MalfunctionOasis Medical2083373-2007-00006
- MURDOCK LID SPECULUM USING STILETTOS 23.5-GAUGEJan 26, 2007InjuryAlcon Manufacturing, LtdMW1041763
- LINDSTROM ASPIRATING SPECULUMDec 16, 1998MalfunctionBausch & Lomb Surgical1932180-1998-00071
- BARRAQUER CHILE SPECULUMJun 11, 1998MalfunctionBausch & Lomb Surgical1932180-1998-00033
- STORZ BARRAQUER EYE SPECULUMMay 8, 1998MalfunctionBausch & Lomb Surgical1932180-1998-00028
Event type breakdown
Registered firms
194 firms currently registered for this product code
Bausch & Lomb Incorporated
Eppelheim Baden-Wurttemberg, DE
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Huaian Tisurg Medical Instruments Co., Ltd.
Huaian City Jiangsu, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
Asol Co.,ltd
huaian Jiangsu, CN
Akriti Ophthalmic Private Limited
Hyderabad Telangana, IN
Accutome, Inc.
Malvern, PA, US
Retivue Llc
Charlottesville, VA, US
Surgical Instrument Manufacturers, Llc
FENTON, MO, US
Suban Instruments Hungary Co.
DEBRECEN Hajdu-Bihar, HU
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Epsilon Eye Care Pvt., Ltd.
MUMBAI Maharashtra, IN
Teleflex Medical Llc
Morrisville, NC, US
Integra Lifesciences Corporation
Princeton, NJ, US
Malosa Medical Instruments (changshu) Limited
Changshu Jiangsu, CN
Surgiscape
Sialkot Punjab, PK
Speedway
India Delhi, IN
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Choose Surgical Instruments
Sialkot Punjab, PK
International Science And Technology, Lp
The Woodlands, TX, US
Oertel Medical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Hayden Medical Inc
Valencia, CA, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Inka Surgical Instruments
Jandakot Western Australia, AU
510(k) clearances
11 clearances for this product code
- Stephens InstrumentsNov 1, 2002
K022836 · STEPHENS DISPOSABLE SPECULUM
- Laser Center Dev. Corp.Jul 15, 1998
K981235 · OCULOSTAT
- Eyefix, Inc.Dec 17, 1996
K964289 · EYE FIXATION SPECULUM
- Keeler Instruments, Inc.Oct 31, 1986
K863989 · THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
- Myocure, Inc.Sep 25, 1986
K863664 · OPHTHALMIC SURGICAL SPECULUM
- Visitec Co.Oct 5, 1984
K843196 · VISITEC EYE SPECULUM
- Douglas C. Mckee & Co.Jun 10, 1983
K830430 · EYELID SPECULUM
- Howmedica Corp.Aug 27, 1980
K801969 · ASNIS GUIDED SCREW SYSTEMS