Spatula, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
90 adverse event reports on file
- FINESSE Flex Loop DSPJul 31, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00162
- FINESSE FLEX LOOP DSPMay 29, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00105
- OPH.SPATULAApr 30, 2026MalfunctionKatena Products, Inc.3010692967-2026-00023
- FINESSE FLEX LOOP DSPApr 24, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00083
- FINESSE FLEX LOOP DSPMar 10, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00056
- FINESSE FLEX LOOP DSPMar 6, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00054
- FINESSE FLEX LOOP DSPJan 16, 2026MalfunctionAlcon Grieshaber Ag3003398873-2026-00019
- FINESSE FLEX LOOP DSPOct 23, 2025MalfunctionAlcon Grieshaber Ag3003398873-2025-00396
- FINESSE FLEX LOOP DSPOct 15, 2025MalfunctionAlcon Grieshaber Ag3003398873-2025-00388
- FINESSE FLEX LOOP DSPAug 27, 2025MalfunctionAlcon Grieshaber Ag3003398873-2025-00365
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
163 firms currently registered for this product code
Garish Apparels
Wazirabad Punjab, PK
Instrumentarium Surgical Corp., Inc.
TERREBONNE Quebec, CA
Volgo Care International (private) Limited
Sialkot Punjab, PK
Inami & Co., Ltd.
Bunkyo Tokyo, JP
Sklar Corporation
Malvern, PA, US
Hnm Medical Dba Hnm Total Recon
Miami, FL, US
Stephens Instruments, Inc
LEXINGTON, KY, US
Accutome, Inc.
Malvern, PA, US
Belle Healthcare Technology Co., Ltd.
Suzhou Jiangsu, CN
Suqian Zhengtong Medical Instruments Co. Ltd
CHINA, HK
Teleflex Llc (nadc)
Olive Branch, MS, US
Med2b Ltd.
Kitzingen Bavaria, DE
Med Saver, Inc.
PHOENIXVILLE, PA, US
Aurora Surgical, Llc
St Petersburg, FL, US
Medone Surgical, Inc.
SARASOTA, FL, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Ambler Surgical, Llc
EXTON, PA, US
Kalson Surgical
Sialkot Punjab, PK
Synergy Health Sterilisation Uk Ltd
Berkshire Reading, GB
Beaver-visitec International, Ltd
BIDFORD-ON-AVON Warwickshire, GB
Medetz Surgical Instruments
Jupiter, FL, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Steris Corporation
Saint Louis, MO, US
Kazan Medical Instruments Plant Joint Stock Compan
KAZAN Tatarstan, RU
Bilink International Inc.
JODHPUR Rajasthan, IN
510(k) clearances
6 clearances for this product code
- Keeler Instruments, Inc.Oct 31, 1986
K863990 · THORNTON TITANIUM SILVER SPATULA
- American V. MuellerMay 15, 1981
K810937 · ANIS IRRIGATING SPATULA
- Edward Weck, Inc.Aug 13, 1980
K801609 · MADDOX LENS SPATULA CAT. #7245
- Edward Weck, Inc.Aug 12, 1980
K801608 · MCCULLEY CONTINUOUS SUTURE TIGHTNER
- Edward Weck, Inc.Oct 4, 1979
K791983 · SPATULA'S #'S 7618,7248,7240,7242,5108
- Edward Weck, Inc.Dec 16, 1976
K761253 · CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM