Company · US
Molnlycke Health Care, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2014. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRO | Dressing, Wound, Drug | 4 |
| KKX | Drape, Surgical, Antimicrobial | 4 |
| FYA | Gown, Surgical | 3 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 |
| OUW | Infant Positioner, Rx, Use In Highly Monitored Setting | 2 |
| FZW | Expander, Surgical, Skin Graft | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 |
| KGO | Surgeon'S Gloves | 1 |
| KMF | Bandage, Liquid | 1 |
| LZA | Polymer Patient Examination Glove | 1 |
| MSH | Respirator, Surgical | 1 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 1 |
| OXJ | Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2014 | K130852 | AVANCE® FOAM ABDOMINAL DRESSING KIT Molnlycke Health Care | OXJ |
| Feb 12, 2014 | K130040 | MEPITEL AG Molnlycke Health Care | FRO |
| Apr 5, 2013 | K123892 | MEPILEX TRANSFER AG Molnlycke Health Care | FRO |
| Jan 17, 2013 | K122132 | AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM Molnlycke Health Care | OMP |
| Nov 23, 2010 | K101163 | BIOGEL ORTHOPRO INDICATOR UNDERGLOVE Molnlycke Health Care USA | KGO |
| Nov 19, 2010 | K102923 | BARRIER N95 PARTICULATE RESPIRATOR Molnlycke Health Care | MSH |
| Sep 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING Molnlycke Health Care | FRO |
| Jan 25, 2007 | K061554 | MEPILEX AG ABSORBENT SILICONE-COATED DRESSING Molnlycke Health Care | FRO |
| Oct 5, 2006 | K062138 | POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE Molnlycke Health Care, Inc. | LZA |
| Jul 14, 2005 | K051625 | BARRIER SURGICAL DRAPES Molnlycke Health Care, Inc. | KKX |
| May 9, 2005 | K050786 | BARRIER SURGICAL GOWNS Molnlycke Health Care | FYA |
| Jun 10, 2003 | K031131 | KLINIDRAPE SURGICAL DRAPES Molnlycke Health Care | KKX |
| Jul 11, 2000 | K000902 | KLINIDRAPE REINFORCED SURGICAL GOWNS Molnlycke Health Care, Inc. | FYA |
| Jul 5, 2000 | K000901 | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION Molnlycke Health Care, Inc. | FYA |
| Jun 23, 2000 | K000906 | KLINIDRAPE SURGICAL DRAPES Molnlycke Health Care, Inc. | KKX |
| Mar 3, 1999 | K984371 | MEPITEL NON ADHERENT SILICONE DRESSING Molnlycke Health Care, Inc. | MGP |
| Mar 1, 1999 | K984370 | HYPERGEL 20% HYPERTONIC SALINE GEL Molnlycke Health Care, Inc. | MGQ |
| Feb 22, 1999 | K984368 | NORMLGEL 0.9% ISOTONIC SALINE GEL Molnlycke Health Care, Inc. | MGQ |
| Nov 10, 1998 | K983554 | ALLDRESS, ABSORBENT FILM DRESSING Molnlycke Health Care, Inc. | KMF |
| Oct 28, 1998 | K983184 | MEPILEX Molnlycke Health Care, Inc. | MGP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2019 | Molnlycke Health Care, Inc EZ Derm Porcine Xenograft, labeled as the following:
a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03;
b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03;
c. Terminated |
KGN | K935189 |
| Jul 26, 2017 | Molnlycke Health Care, Inc 9x15" Medium Utility Positioner with Cover Terminated |
OUW | None listed |
| Jul 26, 2017 | Molnlycke Health Care, Inc 7x10" Small Utility Positioner with Cover Terminated |
OUW | None listed |
| May 3, 2017 | Molnlycke Health Care, Inc Brennen Skin Graft Mesher.
Surgical instrument designed to expand skin grafts' Open, Classified |
FZW | None listed |
| Sep 8, 2007 | Molnlycke Health Care, Inc Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia Terminated |
None listed | |
| Aug 14, 2003 | Molnlycke Health Care Inc Barrier Hip Sheet with Side Pockets Terminated |
KKX | K780282 |