Product code FRO ยท Class U
Dressing, Wound, Drug
19510(k)s in 12 months (707 all time)
7recalls in 12 months (82 all time)
56recalls that name a 510(k)
Top companies in FRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2018 | Integra LifeSciences Corp. Manuka Honey Wound Gel
Catalogue No: 716597
Product Usage:
Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lace Terminated |
FRO | K101793 |
| Nov 17, 2017 | Z-Medica, LLC QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding woun Terminated |
FRO | K123387 |
| May 17, 2017 | Z-Medica, LLC QuikClot TraumaPad, , sterile, soft, white, X-ray detectable
hemostatic dressing
Part Number 460
Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA
For use as a topica Terminated |
FRO | K123387 |
| Dec 14, 2016 | Oculus Innovative Sciences, Inc. Ceramax Skin Barrier Cream:
NET WT 0.1 OZ (3 g professional sample - not for retail sale)
Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care pr Terminated |
FRO | K152055 |
| Sep 2, 2016 | Advanced Medical Solutions Ltd. ReliaMed Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and ea Terminated |
FRO | None listed |
| Sep 2, 2016 | Advanced Medical Solutions Ltd. ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches Terminated |
FRO | K090453 |
| Jul 7, 2016 | TZ Medical, Inc. Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03
Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following Terminated |
FRO | K040208 |
| Mar 24, 2016 | CareFusion 303, Inc. Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 Terminated |
FRO | K051641 |
| Feb 3, 2016 | Medical Action Industries Inc PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC.
This kit is used by clinicians to change dressings Terminated |
FRO | None listed |
| Oct 14, 2015 | TZ Medical Inc. Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 Terminated |
FRO | K071442 |
| Oct 14, 2015 | TZ Medical Inc. SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07.
Product Usage:
SilverStat is an effective barrier to microbial penetration for moderate to h Terminated |
FRO | None listed |
| May 30, 2015 | Coreva Health Science LLC ActCel
advanced bleeding control
Topical Hemostatic Dressing
2in X 2in (5cm X 5cm)
4in X 4in
Sterile Contents
Soluble Regenerated Cellulose
For Bleeding Control
For external topical and temporary us Terminated |
FRO | K112800 |
| Dec 1, 2014 | Bard Access Systems GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006. Terminated |
FRO | None listed |
| Jul 29, 2014 | Wellspring Pharmaceutical Corporation IPM Wound Gel Rx Wound Dressing
IPM Wound Gel is indicated for the management of wound healing. Terminated |
FRO | K123113 |
| Feb 26, 2013 | Oculus Innovative Sciences Inc Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz..
RX only, Professional Sample, Not for Sale.
Pre-printed tube: MS31071,
Shelf carton: PL51091-08
Atrapro Antipruritic HydroGel is ind Terminated |
FRO | K012945 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz.
Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination.
Anti Terminated |
FRO | K093585 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz.
99.999% Reduction In-solution in 30 seconds.
MRSA - Staphylococcus aureus
VFR - Enterococcus faecalis
Acinetobacter baumannii
Terminated |
FRO | K041161 K090206 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Puracyn OTC;
Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert.
Kills 99.99% of Staph, MRSA, Strep and other Infectious Germ Terminated |
FRO | K090206 |
| Jan 11, 2012 | Oculus Innovative Sciences Inc Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL)
Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorit Terminated |
FRO | K041161 K090206 |
| Nov 29, 2011 | Acrymed Incorporated ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Terminated |
FRO | K061232 |
| Apr 7, 2009 | Integra LifeSciences Corp. Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number Terminated |
FRO | K021792 |
| May 31, 2007 | Kensey Nash Corp ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box. Terminated |
FRO | K061772 |
| May 31, 2007 | Kensey Nash Corp FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box. Terminated |
FRO | K061772 |
| May 31, 2007 | Kensey Nash Corp TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the Shie Terminated |
FRO | K061772 |
| Apr 4, 2007 | Integra Biotechnical LLC ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625 Terminated |
FRO | None listed |
| Feb 7, 2007 | Belcher Pharmaceuticals Inc. Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle. Terminated |
FRO | K042400 |
| May 4, 2006 | Southwest Technologies Inc Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate bo Terminated |
FRO | K872165 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic ban Terminated |
FRO | K033709 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Terminated |
FRO | K030836 |
| Nov 16, 2005 | Vascular Solutions, Inc. D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage Terminated |
FRO | K030836 |
| Oct 4, 2005 | B. Braun Medical, Inc. D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. Terminated |
FRO | K030836 |
| Nov 30, 2004 | 3M Company / Medical Division 3M nexcare First Aid HoldFast Roll Gauze cat # HR-2R Lot # 4267. 3M Health Care St. Paul, MN 55144-1000. 1 Roll, 2 in. x 4.1 yards (stretched). Immediate product packaging (formed plastic with Terminated |
FRO | None listed |
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