Company ยท US
American Threshold Industries, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1997. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FYC | Gown, Isolation, Surgical | 4 |
| FRG | Wrap, Sterilization | 2 |
| FYF | Cap, Surgical | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
| KME | Bedding, Disposable, Medical | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 |
| FXX | Mask, Surgical | 1 |
| HAX | Tong, Skull For Traction | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 |
| LDQ | 1 | |
| LGM | Chamber, Patient Isolation | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 1997 | K971483 | SECURE-WRAP (TM) STERILIZATION WRAP American Threshold Industries, Inc. | FRG |
| Jan 5, 1996 | K953879 | SURGEON'S CAP American Threshold Industries, Inc. | FYF |
| Jan 5, 1996 | K953878 | BOUFFANT CAP American Threshold Industries, Inc. | FYF |
| Sep 25, 1995 | K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN American Threshold Industries, Inc. | FYC |
| Sep 25, 1995 | K952114 | KOOL GARD SINGLES GOWN American Threshold Industries, Inc. | FYC |
| Sep 5, 1995 | K952116 | COVER GOWN American Threshold Industries, Inc. | FYC |
| Nov 12, 1993 | K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK American Threshold Industries, Inc. | HOY |
| Aug 17, 1992 | K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE American Threshold Industries, Inc. | HAX |
| Jun 22, 1992 | K915740 | DISPOSABLE O.R. TOWEL, STERILE American Threshold Industries, Inc. | KKX |
| Jul 25, 1991 | K912110 | DISPOSABLE O.R. TOWEL American Threshold Industries, Inc. | KKX |
| Sep 12, 1989 | K894383 | DISPOSABLE SHOE COVER American Threshold Industries, Inc. | FXP |
| May 17, 1985 | K851823 | DISPOSABLE ISOLATION GOWN American Threshold Industries, Inc. | FYC |
| Feb 13, 1984 | K832487 | DRAW SHEET, ANTI-MICROBIAL American Threshold Industries, Inc. | KME |
| Feb 13, 1984 | K832486 | PILLOW COVER, ANTI-MICROBIAL American Threshold Industries, Inc. | KME |
| Feb 4, 1984 | K832483 | MATTRESS COVER, ANTI-MICROBIAL American Threshold Industries, Inc. | FMW |
| Apr 15, 1983 | K830473 | NOVA GAUZE American Threshold Industries, Inc. | NAB |
| Apr 13, 1983 | K831062 | ISOLATION MASK I.C.S. American Threshold Industries, Inc. | LGM |
| Sep 30, 1982 | K822484 | INFECTION CONTROL TOWEL American Threshold Industries, Inc. | LDQ |
| Mar 20, 1981 | K810646 | OR/CS WRAP American Threshold Industries, Inc. | FRG |
| Jun 4, 1980 | K801036 | SURGICAL MASK American Threshold Industries, Inc. | FXX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||