Cystotome
Ophthalmic · 21 CFR 886.4350
Recent MDR events
30 adverse event reports on file
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 14, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00022
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 14, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00023
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 13, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00018
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 13, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00019
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 13, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00020
- IRRIG CYSTOTOME FORMED .50MM (PEARCE) (10/SP)May 13, 2026MalfunctionBeaver-visitec International, Inc.1211998-2026-00021
- CYSTOTOME IRRIGATING 27G 5/8IN (10/SP)Apr 29, 2026InjuryBeaver-visitec International, Inc.1211998-2026-00016
- ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOMEJul 9, 2025InjuryAlcon Research, Llc - Alcon Precision Device2523835-2025-00744
- ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOMEMar 7, 2025InjuryAlcon Research, Llc - Alcon Precision Device2523835-2025-00248
- ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMICFeb 28, 2025InjuryAlcon Research, Llc - Alcon Precision Device2523835-2025-00212
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
82 firms currently registered for this product code
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Med-logics, Inc.
Athens, TX, US
Cbr Enterprise Limited
Hong Kong, HK
Sterimedix Ltd.
REDDITCH Worcestershire, GB
Teleflex Llc (nadc)
Olive Branch, MS, US
Ambler Surgical, Llc
EXTON, PA, US
Sterigenics U.s., Llc
Corona, CA, US
Beaver-visitec International, Inc.
Waltham, MA, US
Beaver-visitec International, Inc.
Ciudad Juarez Chihuahua, MX
Oasis Medical, Inc.
Glendora, CA, US
Fetzer Medical Gmbh & Co.kg
Tuttlingen Baden-Wurttemberg, DE
Millennium Surgical Corp
Schaumburg, IL, US
Bausch & Lomb Incorporated
Rochester, NY, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Surgistar, Inc.
VISTA, CA, US
Jedmed Instrument Company
Saint Louis, MO, US
Rumex Baltics Sia
Riga, LV
Rumex International Co.
Tampa, FL, US
Platinum Focus Group Ltd.
London London, City of, GB
Teleflex Medical Llc
Morrisville, NC, US
Walcott Rx Products, Inc.
Ocean View, NJ, US
Bausch & Lomb Incorporated
Manchester, MO, US
Epsilon Eye Care Pvt., Ltd.
MUMBAI Maharashtra, IN
Oasis Medical, Inc.
GLENDORA, CA, US
Bis Mastermed
Kosice Kosicky, SK
510(k) clearances
20 clearances for this product code
- Sterilab, Inc.May 16, 1996
K961524 · STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
- Myocure, Inc.May 3, 1988
K880345 · CYSTOTOMES/KNIFES
- Advanced Surgical Products, Inc.Apr 13, 1988
K874976 · PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
- Advanced Surgical Products, Inc.Apr 13, 1988
K874993 · PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
- Advanced Surgical Products, Inc.Apr 13, 1988
K875001 · PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
- Advanced Surgical Products, Inc.Apr 13, 1988
K874983 · PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
- Advanced Surgical Products, Inc.Apr 13, 1988
K874997 · PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
- Advanced Surgical Products, Inc.Apr 13, 1988
K874975 · PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME