Medical Device Manufacturer · TW , Taipei, Taiwan

Coreleader Biotech Co., Ltd.

9 submissions · 9 cleared · Since 2011
9
Total
9
Cleared
0
Denied

Coreleader Biotech Co., Ltd. — FDA 510(k) Submissions

Coreleader Biotech Co., Ltd. has submitted 9 FDA 510(k) premarket notifications since 2011, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dressing, Wound, Drug, Hemostatic Wound Dressing Without Thrombin Or Other Biologics, Wound Dressing With Animal-derived Material(s), Elastomer, Silicone, For Scar Management . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
HEMO-Bandage
K151204 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Jul 2015 87d
BIOS KING BIOCELLULOSE FILM
K141382 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Feb 2015 259d
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
K123394 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Jun 2013 216d
CORELEADER COLLA-ALGI FIBER MODEL CAW
K111578 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Sep 2011 108d
CORELEADER SCAR-DIMMER
K111733 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Sep 2011 93d
CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · QSY Hemostatic Wound Dressing... · General & Plastic Surgery
Sep 2011 338d
CORELEADER ALGIPLASTER MODEL AP 050501
K102942 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Jun 2011 261d
CORELEADER COLLA-PAD MODEL CS 03030
K102946 · KGN Wound Dressing With... · General & Plastic Surgery
May 2011 228d
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
K102943 · FRO Dressing, Wound, Drug · General & Plastic Surgery
Apr 2011 190d
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