Lamp, Operating-room
General, Plastic Surgery · 21 CFR 878.4580
Recent MDR events
232 adverse event reports on file
- UNK - RETRACTOR: SYNFRAMEDec 19, 2025MalfunctionSynthes Gmbh8030965-2025-12798
- SYNFRAME TUBE-TO-TUBE CLAMPDec 17, 2025MalfunctionSynthes Gmbh8030965-2025-12715
- SYNFRAME TUBE-TO-TUBE CLAMPDec 17, 2025MalfunctionSynthes Gmbh8030965-2025-12716
- SYNFRAME ANGLED ROD HOLDERSep 25, 2025MalfunctionSynthes Gmbh8030965-2025-09746
- SYNFRAME CONNECTING RODAug 4, 2025MalfunctionSynthes Gmbh8030965-2025-07984
- SYNFRAME ANGLED ROD HOLDERJul 28, 2025MalfunctionSynthes Gmbh8030965-2025-07598
- SYNFRAME ANGLED RODJul 28, 2025MalfunctionSynthes Gmbh8030965-2025-07592
- SYNFRAME ANGLED ROD HOLDERJul 28, 2025MalfunctionSynthes Gmbh8030965-2025-07593
- SYNFRAME ANGLED RODJul 28, 2025MalfunctionSynthes Gmbh8030965-2025-07594
- TRULIGHTJun 19, 2025MalfunctionBaxter Healthcare Corporation3003184737-2025-00002
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
38 firms currently registered for this product code
Zhejiang Honsun Medical Technology Co., Ltd.
Wenzhou City Zhejiang, CN
Baxter Medical Systems Gmbh + Co. Kg
Munich Bavaria, DE
Sunoptic Technologies, Llc
JACKSONVILLE, FL, US
Hefei Mt Medical Co.,ltd.
Hefei Anhui, CN
Better Medical Technology Co., Ltd.
Foshan City Guangdong, CN
Caf Medical Solutions Inc
Hockley, TX, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Synthes (usa) Products Llc
West Chester, PA, US
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Shanghai Pax Medical Instrument Co., Ltd.
Shanghai, CN
Ads Dental System Inc.
Ontario, CA, US
Hebei Webian Medical Instrument Trading Co., Ltd
SHIJIAZHUANG CITY Hebei, CN
Guangzhou Ajax Medical Equipment Co Ltd
Guangzhou Guangdong, CN
Jiangsu Yongfa Medical Equipment Technology Co., Ltd
Zhangjiagang City Jiangsu, CN
Eclipse Prism Medical Devices Pvt. Ltd
RABALE, NAVI MUMBAI Maharashtra, IN
Jiangsu Saikang Medical Equipment Co., Ltd
Zhangjiagang Jiangsu, CN
Synthes Gmbh
Selzach Solothurn, CH
Gamamed Vascular Systems Inc.
Loveland, CO, US
Pcb Holding Llc.
Pewee Valley, KY, US
Nanjing Yanan Special Lighting Factory
Nanjing Jiangsu, CN
Baxter Medical Systems Gmbh + Co. Kg
SAALFELD Thuringia, DE
Jabil Switzerland Manufacturing Gmbh (hagendorf)
Hagendorf Solothurn, CH
Mark Enterprises
Nashik Maharashtra, IN
510(k) clearances
5 clearances for this product code
- AculuxJun 23, 2000
K001223 · ACULUX, MODEL AX3001, AX3002
- Synthes (Usa)Dec 6, 1999
K993314 · SYNTHES LIGHT GUIDE
- American Sterilizer Co.Oct 17, 1978
K781581 · SURGICAL LIGHT 22 SERIES
- Sybron Corp.May 23, 1977
K770812 · HANDLES, LIGHT, SURGICAL, STEOILE
- Amsco Co.Jan 26, 1977
K761018 · SURGICAL LIGHT - CHALLENGE 22 SERIES