Company ยท US
Allegiance Healthcare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2003. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 10 |
| KGO | Surgeon'S Gloves | 9 |
| FYA | Gown, Surgical | 8 |
| LYY | Latex Patient Examination Glove | 8 |
| FRG | Wrap, Sterilization | 5 |
| DXC | Clamp, Vascular | 3 |
| IMD | Pack, Hot Or Cold, Disposable | 3 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 |
| LZA | Polymer Patient Examination Glove | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| FCG | Biopsy Needle | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| FYC | Gown, Isolation, Surgical | 1 |
| GBX | Catheter, Irrigation | 1 |
| GCB | Needle, Catheter | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 |
| KNW | Instrument, Biopsy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 2, 2003 | K023673 | AIRLIFE DEMAND NASAL CANNULA Allegiance Healthcare Corp. | NFB |
| May 1, 2003 | K023602 | SMALL VOLUME NEBULIZER Allegiance Healthcare Corporation | CAF |
| Feb 11, 2003 | K023419 | TRILAMINATE DRAPES/TIBURON Allegiance Healthcare Corp. | KKX |
| Jan 15, 2003 | K024120 | MODIFICATION TO TEMNO BIOPSY NEEDLES Allegiance Healthcare Corp. | FCG |
| Jan 9, 2003 | K024292 | MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM Allegiance Healthcare Corp. | LYY |
| Dec 18, 2002 | K024102 | DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Allegiance Healthcare Corp. | LYY |
| Nov 6, 2002 | K023425 | DRAPES WITH ABSORBENT REINFORCEMENT Allegiance Healthcare Corp. | KKX |
| Oct 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. | LZA |
| Oct 9, 2002 | K023170 | NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. | LZA |
| Oct 2, 2002 | K023167 | BREATHABLE SURGICAL GOWN Allegiance Healthcare Corp. | FYA |
| Aug 20, 2002 | K012931 | GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM Allegiance Healthcare Corp. | FRG |
| Jul 5, 2002 | K020818 | POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS Allegiance Healthcare Corp. | LYY |
| Mar 18, 2002 | K020593 | CONVERTORS SMS POLYOLEFIN GOWN Allegiance Healthcare Corp. | FYA |
| Dec 17, 2001 | K013302 | DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM Allegiance Healthcare Corp. | KGO |
| Sep 24, 2001 | K012984 | BREATHABLE IMPERVIOUS GOWNS Allegiance Healthcare Corp. | FYA |
| Sep 24, 2001 | K012149 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN, CHEMOTHERAPY LABELING CLAIM Allegiance Healthcare Corp. | LYY |
| Aug 14, 2001 | K011721 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES Allegiance Healthcare Corp. | KGO |
| Jul 13, 2001 | K011078 | MALLEABLE SHAFT CLAMP Allegiance Healthcare Corp. | DXC |
| Jun 8, 2001 | K011132 | AIRLIFE HEPA FILTER Allegiance Healthcare Corp. | CAH |
| Jun 7, 2001 | K010862 | ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER Allegiance Healthcare Corp. | KGO |
| May 25, 2001 | K011186 | POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES Allegiance Healthcare Corp. | LYZ |
| Feb 15, 2001 | K010211 | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. | LZC |
| Nov 22, 2000 | K003370 | JAMSHIDI MARROW ACQUISITION CRADLE Allegiance Healthcare Corp. | KNW |
| Sep 1, 2000 | K002508 | EQUIPMENT DRAPES Allegiance Healthcare Corp. | KKX |
| Aug 4, 2000 | K983299 | ALLEGIANCE GENESIS CONTAINER SYSTEM Allegiance Healthcare Corp. | FRG |
| Jul 27, 2000 | K001739 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P Allegiance Healthcare Corp. | LYY |
| Jul 14, 2000 | K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 Allegiance Healthcare Corp. | KGO |
| Jun 23, 2000 | K001667 | RESOLVE SURGICAL O.R. TOWELS Allegiance Healthcare Corp. | KKX |
| May 9, 2000 | K001141 | POWDER FREE STERILE LATEX EXAMINATION GLOVES Allegiance Healthcare Corp. | LYY |
| Apr 21, 2000 | K993871 | BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP Allegiance Healthcare Corp. | FRG |
| Apr 21, 2000 | K001189 | MODIFICATION TO CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Mar 30, 2000 | K000697 | MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS Allegiance Healthcare Corp. | BZE |
| Mar 17, 2000 | K000417 | CONVERTORS EQUIPMENT DRAPES Allegiance Healthcare Corp. | KKX |
| Feb 18, 2000 | K994244 | CONVERTORS SURGICAL GOWNS, STERILE Allegiance Healthcare Corp. | FYA |
| Feb 9, 2000 | K994162 | POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) Allegiance Healthcare Corp. | LYY |
| Jan 12, 2000 | K993795 | CONVERTORS SURGICAL DRAPES Allegiance Healthcare Corp. | KKX |
| Dec 10, 1999 | K993833 | AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS Allegiance Healthcare Corp. | BZE |
| Oct 13, 1999 | K991205 | ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Allegiance Healthcare Corp. | KGO |
| Sep 22, 1999 | K992951 | CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Sep 14, 1999 | K992171 | COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Allegiance Healthcare Corp. | KGO |
| Aug 25, 1999 | K983719 | BIOSHIELD EXPRESS STERILIZATION WRAP Allegiance Healthcare Corp. | FRG |
| Aug 12, 1999 | K992514 | CONVERTORS BREATHABLE SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Jul 13, 1999 | K991992 | ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES Allegiance Healthcare Corp. | KGO |
| Jun 25, 1999 | K991928 | MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS Allegiance Healthcare Corp. | GCJ |
| May 18, 1999 | K991589 | FLEXIBLE VASCULAR CLAMP, VERSION 2 Allegiance Healthcare Corp. | DXC |
| May 13, 1999 | K991484 | AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006 Allegiance Healthcare Corp. | BTT |
| Apr 16, 1999 | K991034 | CONVERTORS SURGICAL GOWNS Allegiance Healthcare Corp. | FYA |
| Feb 10, 1999 | K990300 | SUPRASHIELD EXPRESS STERILIZATION WRAP Allegiance Healthcare Corp. | FRG |
| Jan 21, 1999 | K982652 | ALLEGIANCE PORTA-WARM MATTRESS Allegiance Healthcare Corp. | IMD |
| Aug 24, 1998 | K982369 | CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS Allegiance Healthcare Corp. | FYC |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2003 | Allegiance Healthcare Corp. Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case Terminated |
KKX | K002419 |