3M Healthcare
St. Paul, MN, US
3M Healthcare appears in FDA device records in St. Paul, MN. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for 3M Healthcare between 1991 and 2020. The busiest year on record is 1997, with 5. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 5 |
| 1998 | 4 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | QKM | Substantially Equivalent | |
| K191355 | 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask | FXX | Substantially Equivalent | |
| K180874 | 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield | FXX | Substantially Equivalent | |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | NJM | Substantially Equivalent | |
| K171116 | 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | MSH | Substantially Equivalent | |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | KMF | Substantially Equivalent | |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | KKX | Substantially Equivalent | |
| K974445 | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 | DRX | Substantially Equivalent | |
| K980732 | 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT | DRY | Substantially Equivalent | |
| K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) | GEI | Substantially Equivalent | |
| K974279 | 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) | GEI | Substantially Equivalent | |
| K973472 | 3M CDI H/S CUVETTES WITH HEPARON TREATMENT | DRY | Substantially Equivalent | |
| K973036 | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES | MGP | Substantially Equivalent for Some Indications | |
| K964374 | SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT | DWF | Substantially Equivalent | |
| K964373 | SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT | DWF | Substantially Equivalent | |
| K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | DRX | Substantially Equivalent | |
| K946024 | 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS | KKX | Substantially Equivalent | |
| K946025 | 3M X-LARGE SHEET #7979/ #7979NS | KKX | Substantially Equivalent | |
| K941388 | 3M FLUID IRRIGATION SYSTEM | HRX | Substantially Equivalent | |
| K905539 | 3M 6830 ELECTRODE | GXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator
- HRXArthroscope
- KMFBandage, Liquid
- NJMBracket, Ceramic, Orthodontic
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KKXDrape, Surgical, Antimicrobial
- MGPDressing, Wound And Burn, Occlusive
- GXYElectrode, Cutaneous
- DRXElectrode, Electrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FXXMask, Surgical
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- MSHRespirator, Surgical
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain