FDA 510(k) Applications Submitted by Angela L. Bunn
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090858 |
03/30/2009 |
PARIETEX MONOFILAMENT POLYESTER MESH |
SOFRADIM PRODUCTION |
| K101163 |
04/26/2010 |
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE |
MOLNLYCKE HEALTH CARE USA |
| K151872 |
07/09/2015 |
Avance Y-Connector S |
MOLNLYCKE HEALTH CARE, US LLC |
| K243010 |
09/26/2024 |
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with S |
Owens & Minor (O&M) Halyard, Inc. |
| K053562 |
12/21/2005 |
ZIMMER COLLAGEN REPAIR PATCH |
TISSUE SCIENCE LABORATORIES, PLC |
| K130040 |
01/07/2013 |
MEPITEL AG |
MOLNLYCKE HEALTH CARE |
| K050213 |
01/31/2005 |
FRESHLOOK ONE-DAY COLOR CONTACT LENS |
CIBA VISION CORPORATION |
| K130852 |
03/28/2013 |
AVANCE« FOAM ABDOMINAL DRESSING KIT |
MOLNLYCKE HEALTHCARE |
| K111413 |
05/20/2011 |
BIOGEL (R) INDICATOR (R) UNDERGLOVE |
MOLNLYCKE HEALTHCARE, US LLC |
| K122132 |
07/18/2012 |
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM |
MOLNLYCKE HEALTH CARE |
| K112257 |
08/05/2011 |
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTH CARE US, LLC |
| K002868 |
09/13/2000 |
BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER |
C.R. BARD, INC. |
| K993840 |
11/12/1999 |
BARD UROFORCE BALLOON DILATION CATHETER |
C.R. BARD, INC. |
| K141847 |
07/09/2014 |
AVANCE FOAM DRESSING KITS |
MOLNLYCKE HEALTH CARE US, LLC |
| K112089 |
07/21/2011 |
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTHCARE, US LLC |
| K123892 |
12/18/2012 |
MEPILEX TRANSFER AG |
MOLNLYCKE HEALTH CARE |
| K220541 |
02/25/2022 |
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves |
O&M Halyard, Inc. |
| K220547 |
02/25/2022 |
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves |
O&M Halyard, Inc. |
| K182096 |
08/03/2018 |
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs |
Owens & Minor Halyard, Inc. |
| K232807 |
09/12/2023 |
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) |
Owens & Minor (O&M) Halyard, Inc. |
| K232812 |
09/12/2023 |
Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62 |
Owens & Minor (O&M) Halyard, Inc. |
| K182851 |
10/10/2018 |
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
| K183132 |
11/13/2018 |
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs |
O & M Halyard, Inc. |
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