Company ยท US
I M, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1992. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FMF | Syringe, Piston | 2 |
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 2 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 2 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 2 |
| HRQ | Hemostat | 2 |
| FPA | Set, Administration, Intravascular | 1 |
| FRN | Pump, Infusion | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 1 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 1 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 1 |
| HBA | Neurosurgical Paddie | 1 |
| HDR | Cap, Cervical | 1 |
| HFW | Clamp, Umbilical | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 |
| JWT | Antigen, Cf, Aspergillus Spp. | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 1 |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 30, 1992 | K914600 | NEUROLOGICAL SPONGE I M, Inc. | HBA |
| Jul 17, 1989 | K892389 | BIOPSY KIT I M, Inc. | LRO |
| Jun 23, 1988 | K881363 | SYRINGE PREFILLED WITH WATER I M, Inc. | KOD |
| Apr 27, 1988 | K880753 | UMBILICAL CORD CLAMP I M, Inc. | HFW |
| Oct 20, 1987 | K872741 | NUTRIPUMP I M, Inc. | FRN |
| May 8, 1987 | K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 I M, Inc. | NAD |
| Dec 11, 1986 | K863785 | MAKLER CATHETER I M, Inc. | HDR |
| Dec 10, 1985 | K854155 | STERILE SALINE SOLUTION I M, Inc. | KMJ |
| Oct 17, 1985 | K853287 | HUBOUT I M, Inc. | FPA |
| Oct 4, 1985 | K853288 | FEEDING UNITS & TUBES I M, Inc. | KNT |
| Aug 21, 1985 | K853286 | STAPLE REMOVER I M, Inc. | |
| Jan 18, 1985 | K844062 | FORCEPS & HAMOSTATS I M, Inc. | GEN |
| Nov 19, 1984 | K844063 | SCISSORS GENERAL HOSPITAL I M, Inc. | |
| Nov 7, 1984 | K844152 | HEMSTATS I M, Inc. | HRQ |
| Nov 7, 1984 | K844151 | SETS AND TRAYS I M, Inc. | |
| Jan 10, 1984 | K833399 | SYRINGE I M, Inc. | FMF |
| Dec 12, 1983 | K833435 | MULTI PURPOSE SYRINGE I M, Inc. | FMF |
| Sep 1, 1983 | K831795 | FIRST AID KITS I M, Inc. | KDD |
| Aug 16, 1983 | K831794 | SETS & TRAYS I M, Inc. | |
| Aug 8, 1983 | K831796 | URINE BAG SYSTEM I M, Inc. | KNX |
| Jul 19, 1983 | K831798 | DISPOSABLE SCALPELS I M, Inc. | KDC |
| Jul 19, 1983 | K831797 | HEMOSTATS I M, Inc. | HRQ |
| Jul 18, 1983 | K831799 | PLASTIC DISPOSABLE RAZOR I M, Inc. | LDQ |
| Feb 1, 1979 | K782070 | REAGENT, COCCI LATEX I M, Inc. | GMG |
| Apr 28, 1978 | K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM I M, Inc. | GMD |
| Mar 17, 1978 | K770527 | CANDIDA IMMUNODIFFUSION KIT I M, Inc. | GMI |
| Nov 16, 1976 | K760839 | VASPAR, SEALANT FOR FERMENTATIONS I M, Inc. | |
| Nov 16, 1976 | K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. I M, Inc. | LEB |
| Nov 16, 1976 | K760837 | POTASSIUM HYDROXIDE W/GLYCEROL MTG FL. I M, Inc. | |
| Nov 16, 1976 | K760825 | FUNGAL IMMUNODIFFUSION KIT I M, Inc. | |
| Nov 1, 1976 | K760836 | NEGATIVE CONTROL SERUM I M, Inc. | |
| Nov 1, 1976 | K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) I M, Inc. | KFG |
| Nov 1, 1976 | K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) I M, Inc. | GMH |
| Nov 1, 1976 | K760833 | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) I M, Inc. | KFH |
| Nov 1, 1976 | K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) I M, Inc. | GMK |
| Nov 1, 1976 | K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) I M, Inc. | GMK |
| Nov 1, 1976 | K760830 | ASPERGILLUS MYCELIAL ANTIGEN I M, Inc. | JWT |
| Nov 1, 1976 | K760829 | COCCIDIOIDES MYCELIAL ANTIGEN I M, Inc. | GMG |
| Nov 1, 1976 | K760828 | BLASTOMYCES YEAST ANTIGEN I M, Inc. | JJJ |
| Nov 1, 1976 | K760827 | HISTOPLASMA YEAST ANTIGEN I M, Inc. | GMJ |
| Nov 1, 1976 | K760826 | HISTOPLASMA MYCELIAL ANTIGEN I M, Inc. | GMJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||