Loupe, Binocular, Low Power
Ophthalmic · 21 CFR 886.5120
Recent MDR events
4 adverse event reports on file
- MAGNIFYING LPE 3.0X BLK R 13IN TO 16IN WRKG DISTNov 4, 2022InjuryIntegra Lifesciences Mansfield3014334038-2022-00243
- MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DISTJun 21, 2022MalfunctionIntegra Lifesciences Mansfield3014334038-2022-00124
- MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DISTSep 26, 2019MalfunctionIntegra York, Pa Inc.2523190-2019-00116
- LED LOUPES LIGHT UNITFeb 26, 2019MalfunctionIntegra York, Pa Inc.2523190-2019-00026
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
46 firms currently registered for this product code
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
I.c.lercher-solutions Gmbh
Stockach Baden-Wurttemberg, DE
Zumax Medical Co, Ltd.
SUZHOU,JIANGSU, CN
Jiangsu Yuchang Optical Glasses Co., Ltd
Danyang Jiangsu, CN
Bronze Drive Location
Boise, ID, US
Examvision A/s
samsoe Midtjylland, DK
Riverpoint Medical Llc
Portland, OR, US
Zhejiang Fude Medphotonic Co.,ltd.
Huzhou City Zhejiang, CN
Univet Loupes Spa
Rezzato Brescia, IT
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Henan Baistra Medical Devices Limited
Zhengzhou Henan, CN
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Hospital Equipment Mfg. Co.
NOIDA Uttar Pradesh, IN
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Chamfond Biotech Co., Ltd.
Nanjing Jiangsu, CN
Integra Lifesciences Corporation
Princeton, NJ, US
Aidite (qinhuangdao) Technology Co., Ltd
Qinhuangdao City Hebei, CN
Shenzhen Upcera Digital Dental Technology Co., Ltd
Shenzhen Guangdong, CN
Vorotek
Moolap Victoria, AU
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Toyo Medical Co.
Doral, FL, US
Keeler Ltd.
WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
Bio-art Equipamentos Odontologicos Ltda.
SAO CARLOS Sao Paulo, BR
510(k) clearances
3 clearances for this product code