ClearanceBrief
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)
Get daily alerts for FROSample briefCSV

Top companies in FRO

DateFirm and productCodeLinked 510(k)
Mar 6, 2018Integra 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
FROK101793
Nov 17, 2017Z-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
FROK123387
May 17, 2017Z-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
FROK123387
Dec 14, 2016Oculus 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
FROK152055
Sep 2, 2016Advanced 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
FRONone listed
Sep 2, 2016Advanced 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
FROK090453
Jul 7, 2016TZ 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
FROK040208
Mar 24, 2016CareFusion 303, Inc.
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Terminated
FROK051641
Feb 3, 2016Medical 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
FRONone listed
Oct 14, 2015TZ Medical Inc.
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Terminated
FROK071442
Oct 14, 2015TZ 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
FRONone listed
May 30, 2015Coreva 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
FROK112800
Dec 1, 2014Bard Access Systems
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
Terminated
FRONone listed
Jul 29, 2014Wellspring Pharmaceutical Corporation
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Terminated
FROK123113
Feb 26, 2013Oculus 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
FROK012945
Jan 11, 2012Oculus 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
FROK093585
Jan 11, 2012Oculus 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
FROK041161
K090206
Jan 11, 2012Oculus 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
FROK090206
Jan 11, 2012Oculus 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
FROK041161
K090206
Nov 29, 2011Acrymed 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
FROK061232
Apr 7, 2009Integra 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
FROK021792
May 31, 2007Kensey Nash Corp
ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01. The product is sold 5 per box.
Terminated
FROK061772
May 31, 2007Kensey Nash Corp
FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02. The product is sold 5 per box.
Terminated
FROK061772
May 31, 2007Kensey 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
FROK061772
Apr 4, 2007Integra Biotechnical LLC
ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
Terminated
FRONone listed
Feb 7, 2007Belcher Pharmaceuticals Inc.
Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.
Terminated
FROK042400
May 4, 2006Southwest 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
FROK872165
Nov 16, 2005Vascular 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
FROK033709
Nov 16, 2005Vascular 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
FROK030836
Nov 16, 2005Vascular 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
FROK030836
Oct 4, 2005B. Braun Medical, Inc.
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Terminated
FROK030836
Nov 30, 20043M 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
FRONone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.