Company ยท US
Medical Action Industries Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2005. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OVN | Suture Kit | 7 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 5 |
| FPA | Set, Administration, Intravascular | 3 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FRG | Wrap, Sterilization | 1 |
| FRL | Fiber, Medical, Absorbent | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| HHT | Spatula, Cervical, Cytological | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| MCZ | Suture Removal Kit | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2005 | K042526 | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX Medical Action Industries, Inc. | KKX |
| Nov 8, 2004 | K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 Medical Action Industries, Inc. | HHT |
| Nov 4, 2002 | K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L Medical Action Industries, Inc. | HIB |
| Mar 20, 1995 | K946019 | SURGICLA INSTRUMENT KIT Medical Action Industries, Inc. | FRG |
| Sep 11, 1992 | K923846 | BURN DRESSING Medical Action Industries, Inc. | NAB |
| Dec 22, 1988 | K884826 | GAUZE SPONGE Medical Action Industries, Inc. | EFQ |
| Mar 26, 1981 | K810685 | SUTURE REMOVAL KIT Medical Action Industries, Inc. | GEN |
| Feb 4, 1981 | K810184 | LAPAROTOMY SPONGE Medical Action Industries, Inc. | GDY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2019 | Medical Action Industries Inc Laparotomy Sponge with the following product description and model numbers:
1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300;
2. Lap 18X18 XR (5 each/pack, 40 Terminated |
GDY | None listed |
| Nov 27, 2018 | Medical Action Industries Inc Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap.
intended use: Lapar Terminated |
GDY | None listed |
| Dec 11, 2017 | Medical Action Industries Inc Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile
This OR towel product is intended for external use only. These towels are intended to Terminated |
FRL | None listed |
| Apr 19, 2017 | Medical Action Industries Inc Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs).
Intended for packing and absorption externally or within patient wounds in various procedures or su Open, Classified |
GDY | None listed |
| Apr 19, 2017 | Medical Action Industries Inc White OR Towels, X-Ray Detectable, Sterile, 4 Towels per/pk; 20pk/Cs.
Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases. Open, Classified |
GDY | None listed |
| 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 |
| Jul 1, 2014 | Medical Action Industries Inc Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228 Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
OVN | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC. Terminated |
MCZ | None listed |
| Jul 1, 2014 | Medical Action Industries Inc Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC. Terminated |
OVN | None listed |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977. Terminated |
FPA | K013621 |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498. Terminated |
FPA | K013621 |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B. Terminated |
FPA | K013621 |