Speculum, Ent
General, Plastic Surgery · 21 CFR 878.1800
Recent MDR events
10 adverse event reports on file
- COTTLE NASAL SPEC SZ 4 55MMJan 13, 2023InjuryIntegra Lifesciences Mansfield3014334038-2023-00002
- PAPAVERO-CASPAR SPEC SLIM-PROF 90X13MMAug 9, 2018InjuryAesculap Ag9610612-2018-00352
- NOIR TRANSSPHENOIDAL SPECULA 90X13MMAug 9, 2018MalfunctionAesculap Ag9610612-2018-00353
- NOIR TRANSSPHENOIDAL SPECULA 90X13MMAug 9, 2018MalfunctionAesculap Ag9610612-2018-00351
- PAPAVERO-CASPAR SPEC SLIM-PROF 100X15MMAug 9, 2018InjuryAesculap Ag9610612-2018-00350
- SPECULUM MCO981D DEVEZENov 15, 2017MalfunctionIntegra Microfrance S.a.s.2523190-2017-00136
- PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MMJul 25, 2008MalfunctionAesculap Ag & Co. Kg2916714-2008-00017
- TRANS SPECULUM BLACK 2 3/4 MMAug 7, 2002InjuryIntegra Lifesciences1121308-2002-00023
- PAPAVERO - CASPAR SPECULUMJan 16, 2001MalfunctionAesculap, Inc.2916714-2001-00002
- BASIS EAR NOSE & THROAT MED-CHECK LIGHTOct 2, 1999MalfunctionPolymedica Healthcare, Inc.MW1017299
Event type breakdown
Recalls
2 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-0930-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1433-2024 · View FDA record ↗
Registered firms
230 firms currently registered for this product code
Instrumed International Inc Dba Avalign German Specialty Instruments
SCHAUMBURG, IL, US
Cm Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Instrumentarium Surgical Corp., Inc.
TERREBONNE Quebec, CA
Kls Martin Malaysia Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
E.l. Zepf Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Pilotis Tech Llc
Brookhaven, GA, US
Spiggle & Theis Medizintechnik Gmbh
OVERATH North Rhine-Westphalia, DE
Diligent Medical Services
SIALKOT Punjab, PK
Elmed, Inc.
Glendale Heights, IL, US
Taizhou Honod Medical Co.,ltd
Taizhou Zhejiang, CN
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Technimen Skillers
SIALKOT Punjab, PK
Mclean Medical & Scientific
Saint Paul, MN, US
Little Doctor Electronic(nantong) Co.,ltd
Nantong Jiangsu, CN
Laparomed Private Limited
Mumbai Maharashtra, IN
Ultra Surgical (pvt.) Ltd
SIALKOT Punjab, PK
Bausch & Lomb Incorporated
Rochester, NY, US
Quality Concept (pvt) Ltd.
SIALKOT Punjab, PK
Med Saver, Inc.
PHOENIXVILLE, PA, US
Denzel Medical Gmbh & Co. Kg
NEUHAUSEN Baden-Wurttemberg, DE
Rsb Spine Llc.
Wooster, OH, US
Trademark Plastics Inc.
Riverside, CA, US
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Smi Medical Instruments Gmbh & Co.kg
NEUHAUSEN OB ECK Baden-Wurttemberg, DE
Merced Medical, Inc.
Scottsdale, AZ, US
510(k) clearances
12 clearances for this product code
- Pedia Pals, Inc.Feb 7, 1995
K950086 · PEDIA PALS, INCORPORATED
- Rudolf Riester GmbH & Co. KGOct 8, 1993
K925754 · ECONOM
- Downs Surgical , Ltd.Dec 18, 1985
K853588 · FIBRELIGHT NASAL SPECULA
- Imm Enterprises , Ltd.Mar 6, 1984
K834189 · JAKOBI SURG. INSTRUMENTS #7 44/47
- Treace Medical, Inc.Sep 9, 1982
K822370 · UNIVERSAL SPECULUM HOLDER
- Treace Medical, Inc.Sep 9, 1982
K822373 · EAR SURGERY SPECULUM
- Kelleher Corp.Aug 11, 1982
K822164 · EAR SPECULI
- Xomed, Inc.Jul 10, 1979
K791123 · EAR AND NOSE SPECULA