Headlamp, Operating, Battery-operated
Ophthalmic · 21 CFR 886.4335
Recent MDR events
12 adverse event reports on file
- RONIN X6Jul 13, 2026MalfunctionRonin Surgical Corp.MW5190651
- RONIN X6Dec 8, 2025InjuryRonin Surgical Corp.MW5180139
- RONIN X6 OR HEADLIGHTSep 15, 2025MalfunctionRonin Surgical Corp.MW5176076
- ENOVA PP2 POWER PACKJul 15, 2024MalfunctionEnova Illumination Inc.0002127132-2024-00001
- RONIN SURGICAL CORPDec 25, 2023InjuryRonin Surgical Corp.3013682780-2023-00001
- RONIN X6 SURGICAL HEADLAMP/HEADLIGHTAug 16, 2023InjuryRonin Surgical Corp.MW5144689
- MEDLEDSep 28, 2022MalfunctionRiverpoint Medical3006981798-2022-00033
- HEADLAMP, OPERATING, BATTERY-OPERATEDOct 20, 2021MalfunctionRonin Surgical Corporation12664630
- RONIN X6Jan 5, 2021MalfunctionRonin Surgical Corp.11116235
- MEDLED SAPPHIRESep 10, 2020MalfunctionRiverpoint Medical3006981798-2020-00007
Event type breakdown
Most-reported manufacturers
Registered firms
71 firms currently registered for this product code
Indo-german Surgical Corporation
Mumbai Maharashtra, IN
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Riverpoint Medical Llc
Portland, OR, US
Br Surgical Llc
Jacksonville, FL, US
Power Dental Usa, Inc.
McHenry, IL, US
Qed, Inc.
LEXINGTON, KY, US
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Aspen Surgical Products, Inc.
Caledonia, MI, US
Hayden Medical Inc
Valencia, CA, US
Designs For Vision, Inc.
Bohemia, NY, US
Guilin Yikeshi Medical Device Co Ltd
Guilin Guangxi, CN
Hexamed Pvt Ltd
Sialkot Punjab, PK
Practicon, Inc.
Greenville, NC, US
Kashmir Surgical Works
AMBALA Haryana, IN
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Univet Loupes Spa
Rezzato Brescia, IT
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Synovis Micro Companies Alliance, Inc. (a Subsidiary Of Baxter International Inc.)
BIRMINGHAM, AL, US
Nihon Kohden Corp.
SHINJUKU-KU Tokyo, JP
I.c.lercher-solutions Gmbh
Stockach Baden-Wurttemberg, DE
Nihon Kohden Corporation - Tokorozawa Establishment Advanced Technology Center
Tokorozawa Saitama, JP
Tekmode
Akbarabad, Sialkot Punjab, PK
Nihon Kohden Corporation - Eastern Japan Logistics Center
Sakado City Saitama, JP
Surgident India
NEW DELHI, IN
Jedmed Instrument Company
Saint Louis, MO, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.