American Threshold Industries, Inc.
Walker, MI, US
American Threshold Industries, Inc. appears in FDA device records in Walker, MI. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for American Threshold Industries, Inc. between 1980 and 1997. The busiest year on record is 1984, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 3 |
| 1985 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K953879 | SURGEON'S CAP | FYF | Substantially Equivalent | |
| K953878 | BOUFFANT CAP | FYF | Substantially Equivalent | |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | FYC | Substantially Equivalent | |
| K952114 | KOOL GARD SINGLES GOWN | FYC | Substantially Equivalent | |
| K952116 | COVER GOWN | FYC | Substantially Equivalent | |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | HOY | Substantially Equivalent | |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | HAX | Substantially Equivalent | |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | KKX | Substantially Equivalent | |
| K912110 | DISPOSABLE O.R. TOWEL | KKX | Substantially Equivalent | |
| K894383 | DISPOSABLE SHOE COVER | FXP | Substantially Equivalent | |
| K851823 | DISPOSABLE ISOLATION GOWN | FYC | Substantially Equivalent | |
| K832487 | DRAW SHEET, ANTI-MICROBIAL | KME | Substantially Equivalent | |
| K832486 | PILLOW COVER, ANTI-MICROBIAL | KME | Substantially Equivalent | |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | FMW | Substantially Equivalent | |
| K830473 | NOVA GAUZE | NAB | Substantially Equivalent | |
| K831062 | ISOLATION MASK I.C.S. | LGM | Substantially Equivalent | |
| K822484 | INFECTION CONTROL TOWEL | LDQ | Substantially Equivalent | |
| K810646 | OR/CS WRAP | FRG | Substantially Equivalent | |
| K801036 | SURGICAL MASK | FXX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KMEBedding, Disposable, Medical
- FYFCap, Surgical
- LGMChamber, Patient Isolation
- FMWCover, Mattress (Medical Purposes)
- FXPCover, Shoe, Operating-Room
- KKXDrape, Surgical, Antimicrobial
- NABGauze / Sponge,Nonresorbable For External Use
- FYCGown, Isolation, Surgical
- FXXMask, Surgical
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- HAXTong, Skull For Traction
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain