Company ยท US
3M Health Care, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1996. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FRN | Pump, Infusion | 16 |
| FRC | Indicator, Biological Sterilization Process | 4 |
| KMF | Bandage, Liquid | 3 |
| DRX | Electrode, Electrocardiograph | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| FRW | Scale, Patient | 2 |
| IWZ | Film, Radiographic | 2 |
| KGX | Tape And Bandage, Adhesive | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
| BRX | Stool, Anesthesia | 1 |
| DQD | Stethoscope, Electronic | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 |
| DTY | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 1 |
| FYA | Gown, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 19, 1996 | K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP 3M Health Care, Ltd. | DWB |
| Mar 31, 1995 | K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X 3M Health Care, Ltd. | FRC |
| Mar 6, 1995 | K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM 3M Health Care, Ltd. | KWY |
| Dec 2, 1994 | K941748 | STERI-VAC GAS STERILIZER MODEL 8XL 3M Health Care, Ltd. | FLF |
| Feb 10, 1994 | K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX 3M Health Care, Ltd. | FYA |
| Jan 7, 1994 | K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM 3M Health Care, Ltd. | KIJ |
| Dec 27, 1993 | K932422 | 3M TEGADERM HP TRANSPARENT DRESSING 3M Health Care, Ltd. | KGX |
| Nov 29, 1993 | K932446 | INJECTION SITE 3M Health Care, Ltd. | FPA |
| Nov 10, 1993 | K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO 3M Health Care, Ltd. | DRY |
| Oct 25, 1993 | K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE 3M Health Care, Ltd. | FRN |
| Oct 25, 1993 | K933005 | AVI MODEL 600 SYRINGE PUMP 3M Health Care, Ltd. | FRN |
| Sep 1, 1993 | K930312 | 3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE 3M Health Care, Ltd. | DRX |
| Aug 16, 1993 | K932454 | 3M RED DOT 2330 RESTING EKG ELECTRODE 3M Health Care, Ltd. | DRX |
| Aug 16, 1993 | K926059 | 3M MODEL 200RT RATE TAPER INFUSION PUMP 3M Health Care, Ltd. | FRW |
| Aug 16, 1993 | K926058 | 3M MODEL 280RT RATE TAPER INFUSION PUMP 3M Health Care, Ltd. | FRW |
| Aug 6, 1993 | K930468 | 3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X 3M Health Care, Ltd. | KMF |
| Jul 28, 1993 | K915363 | SARNS 7850 CENTRIFUGAL PUMP (MODIFIED) 3M Health Care, Ltd. | KFM |
| Jul 22, 1993 | K920362 | 3M MODULAR SHOULDER SYSTEM 3M Health Care, Ltd. | KWS |
| Jul 21, 1993 | K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE 3M Health Care, Ltd. | IWZ |
| Jul 20, 1993 | K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE 3M Health Care, Ltd. | IWZ |
| Jun 18, 1993 | K924871 | MODEL 880 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924872 | MODEL 885 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924870 | MODEL 480CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924869 | MODEL 480CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924868 | MODEL 480 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924867 | 285CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924866 | MODEL 285CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| Jun 17, 1993 | K924865 | MODEL 285 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. | FRN |
| May 26, 1993 | K924207 | AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET 3M Health Care, Ltd. | FPA |
| May 26, 1993 | K921925 | MANUAL SURGICAL INSTRUMENTS 3M Health Care, Ltd. | GCJ |
| May 12, 1993 | K924280 | 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M Health Care, Ltd. | KMF |
| Apr 20, 1993 | K923068 | AVI MODEL 3100 INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Mar 31, 1993 | K925618 | 3M REMOVER LOTION PRODUCT NUMBER 86XX 3M Health Care, Ltd. | KOX |
| Dec 23, 1992 | K924487 | RED DOT 2515 CARDIAC SENSOR SYSTEM 3M Health Care, Ltd. | BRX |
| Oct 21, 1992 | K920009 | 3M LITTMANN GRAPHIC DISPLAY SYSTEM 3M Health Care, Ltd. | DQD |
| Sep 18, 1992 | K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 3M Health Care, Ltd. | DWF |
| Aug 10, 1992 | K920794 | BRND SKIN PROTECTION PREP SERIES 33XX 3M Health Care, Ltd. | KMF |
| Jul 16, 1992 | K921051 | 3M PRECISE BRAND INTERNAL SURGICAL STAPLES 3M Health Care, Ltd. | GDW |
| May 26, 1992 | K921073 | AVI MODEL 480CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| May 26, 1992 | K921072 | AVI MODEL 470CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K920681 | AVI MODEL 285CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K920680 | AVI MODEL 275CI INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Apr 6, 1992 | K920588 | AVI MODEL 3000 INFUSION PUMP 3M Health Care, Ltd. | FRN |
| Sep 25, 1991 | K912920 | SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER 3M Health Care, Ltd. | DTZ |
| Sep 25, 1991 | K912915 | SARNS NON-FILTERED VENOUS RESERVOIR 3M Health Care, Ltd. | DTP |
| Aug 9, 1991 | K912871 | INSIDE JOB 3M Health Care, Ltd. | HRX |
| Jul 26, 1991 | K912520 | 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX 3M Health Care, Ltd. | KGX |
| Dec 5, 1990 | K904921 | STERI-VAC(TM) AERATOR MODEL XL 3M Health Care, Ltd. | FLI |
| Nov 5, 1990 | K902654 | CDI (TM) SYSTEM 100 MONITORING SYSTEM 3M Health Care, Ltd. | DTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2003 | 3m Health Care 3M Attest 1264P Biological Indicators, in boxes of 25 per box Terminated |
FRC | None listed |
| Dec 18, 2003 | 3m Health Care 3M Attest 1264 Biological Indicators, in boxes of 100 per box Terminated |
FRC | None listed |
| May 16, 2003 | 3m Health Care 3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ Terminated |
KKX | None listed |
| May 16, 2003 | 3m Health Care 3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ Terminated |
KKX | K801550 |
| Apr 22, 2003 | 3m Health Care N/A Terminated |
FRC | None listed |