Pad, Neonatal Eye
General Hospital · 21 CFR 880.5270
Recent MDR events
27 adverse event reports on file
- NEOTECH PRODUCTSSep 23, 2025InjuryNeotech Products Llc2025917-2025-00004
- EYEMAX21Apr 8, 2021MalfunctionMaxtec1000117260-2021-00003
- EYEMAX2Mar 10, 2021MalfunctionMaxtec, Llc1000117260-2021-00002
- EYEMAX2 PHOTOTHERAPY MASKNov 17, 2020InjuryMaxtec, Llc1722070-2020-00001
- NATUS BILIBAND EYE PROTECTORMar 15, 2019MalfunctionNatus Medical Inc.3018859-2019-00002
- NATUS BILIBAND EYE PROTECTORJan 29, 2019InjuryNatus Medical Inc.MW5083472
- NEOTECHOct 15, 2018InjuryNeotech Products Llc2025917-2018-00112
- NATUS BILIBAND EYE PROTECTORMar 27, 2017MalfunctionNatus Medical Incorporated3018859-2017-00228
- NATUS BILIBAND EYE PROTECTORMar 27, 2017MalfunctionNatus Medical Incorporated3018859-2017-00269
- NATUS BILIBAND EYE PROTECTORMar 27, 2017MalfunctionNatus Medical Incorporated3018859-2017-00243
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
29 firms currently registered for this product code
Guatemala Medical Manufacturing
Villa Canales Guatemala, GT
Ludlow Technical Products Canada, Ltd. (a Division Of Cardinal Health Llc)
GANANOQUE Ontario, CA
Velcromex, S.a. De C.v.
AGUA PRIETA Sonora, MX
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Applied Technology International, Ltd Dba:fabrifoam Products
Exton, PA, US
Salaera, Llc D.b.a Maxtec
Salt Lake City, UT, US
Unimed Medical Supplies Inc
Shenzhen Guangdong, CN
Farstar (wuxi) Medical Equipment Co., Ltd
Wuxi Jiangsu, CN
M&c Specialties And Ivemsa
Mexicali Baja California, MX
Atom Medical Corporation
Sakura-ku, Saitama-shi, JP
Guangdong Tidakang Medical Technology Co., Ltd
ZhongShan City Guangdong, CN
Cardinal Health
Hazelwood, MO, US
Neolight, Llc
Scottsdale, AZ, US
International Biomedical, Ltd.
AUSTIN, TX, US
Ortho And Surgical Products Enterprises S.a.
Villa Canales Guatemala, GT
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
Natus Medical Denmark Aps
TAASTRUP Hovedstaden, DK
Cardinal Health 200, Llc
Waukegan, IL, US
Neotech Products, Llc
Valencia, CA, US
Small Beginnings Inc.
Hesperia, CA, US
Orta Medical Ltd
TZUR YIGAL Central, IL
Tidi Products, Llc
NEENAH, WI, US
Platinum Focus Group Ltd.
London London, City of, GB
Auckland Medical Technology (sichuan) Co. Ltd
Luzhou Sichuan, CN
Posey, S. De R.l. De C.v.
Tijuana Baja California, MX
510(k) clearances
5 clearances for this product code
- Debusk Technology Corp.Jul 3, 1996
K962290 · DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER
- Graphic Controls Corp.Mar 15, 1993
K926118 · LIFE TRACE(R) BILIRUBIN MASK
- Alba Health CareJun 7, 1985
K851918 · INFANT PHOTOTHERAPY MASK
- A & A Medical Supplies Co.Mar 23, 1984
K840894 · PHOTO-THERAPY EYE PROTECTOR
- Montrose Phototherapy SupplyDec 9, 1981
K813214 · INFANT PHOTOTHERAPY MASK