Company ยท US
Ulti-Med Intl., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2011. 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 |
|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 3 |
| FMC | Patient Examination Glove | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| FRG | Wrap, Sterilization | 1 |
| FXO | Suit, Surgical | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| FXX | Mask, Surgical | 1 |
| FYC | Gown, Isolation, Surgical | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 |
| HMP | Pad, Eye | 1 |
| LRP | Tray, Surgical | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 |
| MEG | Syringe, Antistick | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 2, 2011 | K103011 | ULTICARE SAFETY INSULIN SYRINGE Ulti-Med Intl., Inc. | MEG |
| Jun 17, 1993 | K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. | KDD |
| Jun 17, 1993 | K923175 | SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. | FMC |
| Oct 19, 1992 | K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. | KDD |
| Sep 28, 1992 | K922828 | ULCER WOUND TRAY Ulti-Med Intl., Inc. | KKX |
| Feb 24, 1992 | K914244 | STERILE CUSTOM SURGICAL KITS Ulti-Med Intl., Inc. | KDD |
| Dec 4, 1991 | K914431 | ABSORBENT FIBER Ulti-Med Intl., Inc. | NAB |
| Oct 4, 1991 | K912693 | POST OPERATIVE SPONGE Ulti-Med Intl., Inc. | NAB |
| Oct 4, 1991 | K912692 | CONFORMING BANDAGE Ulti-Med Intl., Inc. | NAB |
| Dec 5, 1990 | K904896 | EYE PAD Ulti-Med Intl., Inc. | HMP |
| Jun 12, 1990 | K901465 | ABSORBABLE GAUZE DRAPE Ulti-Med Intl., Inc. | KKX |
| May 11, 1989 | K891717 | PATIENT EXAMINATION GLOVES (VINYL) Ulti-Med Intl., Inc. | LYZ |
| Jan 7, 1988 | K874296 | INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER Ulti-Med Intl., Inc. | FXX |
| Dec 2, 1987 | K874318 | MAXIMUM CONTROL GOWN Ulti-Med Intl., Inc. | FYC |
| Sep 11, 1987 | K873439 | LACERATION TRAY Ulti-Med Intl., Inc. | LRP |
| Sep 9, 1987 | K873175 | CENTRAL SUPPLY ROOM WRAP Ulti-Med Intl., Inc. | FRG |
| Jan 12, 1987 | K865023 | COVER, SHOE OPERATING ROOM Ulti-Med Intl., Inc. | FXP |
| Jan 12, 1987 | K865022 | SURGICAL GARMENTS Ulti-Med Intl., Inc. | FXO |
| Apr 4, 1986 | K860936 | ABSORBENT, FIBER, OPERATING ROOM TOWELS Ulti-Med Intl., Inc. | KKX |
| Aug 15, 1984 | K842572 | GAUZE & LAB SPONGES STERILE & NON Ulti-Med Intl., Inc. | GDY |
| Sep 29, 1983 | K832858 | INTRADISCAL THERAPY TRAY Ulti-Med Intl., Inc. | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||