Company · US
3M Healthcare
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2020. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 4 |
| DRX | Electrode, Electrocardiograph | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 |
| FXX | Mask, Surgical | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| GXY | Electrode, Cutaneous | 1 |
| HRX | Arthroscope | 1 |
| KMF | Bandage, Liquid | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 |
| MSH | Respirator, Surgical | 1 |
| NJM | Bracket, Ceramic, Orthodontic | 1 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2020 | K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3M Healthcare | QKM |
| Sep 11, 2019 | K191355 | 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask 3M Healthcare | FXX |
| Jul 31, 2018 | K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield 3M Healthcare | FXX |
| Mar 16, 2018 | K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 3M Healthcare | NJM |
| Aug 10, 2017 | K171116 | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S 3M Healthcare | MSH |
| Aug 23, 2016 | K153571 | Cavilon Advanced High Endurance Skin Protectant 3M Healthcare | KMF |
| Aug 18, 2014 | K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES 3M Healthcare | KKX |
| Jul 25, 2014 | K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE 3M Healthcare | KKX |
| Jul 26, 1998 | K974445 | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 3M Healthcare | DRX |
| May 15, 1998 | K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT 3M Healthcare | DRY |
| Feb 3, 1998 | K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) 3M Healthcare | GEI |
| Jan 30, 1998 | K974279 | 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) 3M Healthcare | GEI |
| Dec 8, 1997 | K973472 | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT 3M Healthcare | DRY |
| Nov 12, 1997 | K973036 | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES 3M Healthcare | MGP |
| Jun 18, 1997 | K964374 | SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT 3M Healthcare | DWF |
| Jun 18, 1997 | K964373 | SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT 3M Healthcare | DWF |
| Apr 9, 1997 | K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES 3M Healthcare | DRX |
| Feb 8, 1995 | K946024 | 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS 3M Healthcare | KKX |
| Feb 2, 1995 | K946025 | 3M X-LARGE SHEET #7979/ #7979NS 3M Healthcare | KKX |
| Oct 7, 1994 | K941388 | 3M FLUID IRRIGATION SYSTEM 3M Healthcare | HRX |
| May 28, 1991 | K905539 | 3M 6830 ELECTRODE 3M Healthcare | GXY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||