ClearanceBrief
Panels › Ophthalmic › Product code HOZ · Class 2

Sponge, Ophthalmic

Regulation 886.4790

0510(k)s in 12 months (47 all time)
0recalls in 12 months (10 all time)
6recalls that name a 510(k)
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Top companies in HOZ

Company510(k)sRecalls
Ultracell Medical Technologies, Inc.43
Visitec Co.50
Carwild Corporation03
Jedmed Instrument Co.30
Deroyal Industries, Inc.11
Alcon Laboratories10
Alphamed, Inc.10
Ascon Medical Instruments, Ltd.10
Associated Medical Products Co.10
Beaver Visitec International, Inc.01
DateFirm and productCodeLinked 510(k)
Jan 2, 2025Carwild Corporation
Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q770410
Open, Classified		 HOZNone listed
Jan 2, 2025Carwild Corporation
Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical Procedures For Fluid Management Model Number: Q604237
Open, Classified		 HOZK971832
Jan 2, 2025Carwild Corporation
Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206
Open, Classified		 HOZK971832
Mar 1, 2023Beaver Visitec International, Inc.
Ultracell Wick with 80cc Collection Bag, 20/box
Open, Classified		 HOZK920354
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Open, Classified		 HOZNone listed
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825
Open, Classified		 HOZNone listed
Nov 14, 2013DeRoyal Industries Inc
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near
Terminated		 HOZNone listed
Jan 30, 2003Ultracell Medical Technologies
Lasik Spears Blunt (5) Catalog #: U/S32-100
Terminated		 HOZK923922
Jan 30, 2003Ultracell Medical Technologies
PVA Foam Surgical Spears Catalog #: OASIS0525
Terminated		 HOZK923922
Jan 30, 2003Ultracell Medical Technologies
Ultrakleen KSponge II Spears Catalog #: K20-5012
Terminated		 HOZK923922

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