Mallinckrodt Group, Inc.
Mchenry, IL, US
Mallinckrodt Group, Inc. appears in FDA device records in Mchenry, IL. FDA records list 27 510(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
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Mallinckrodt Group, Inc. between 1976 and 1995. The busiest year on record is 1990, with 8. The most recent is 1995, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 1 |
| 1978 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 8 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 2 |
| 1995 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | FOZ | Substantially Equivalent | |
| K945140 | URO-FLO | LJH | Substantially Equivalent | |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | IXR | Substantially Equivalent | |
| K943122 | SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K934664 | HYDRAGOWN | FYA | Substantially Equivalent | |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | IXR | Substantially Equivalent | |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | DXT | Substantially Equivalent | |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | LLZ | Substantially Equivalent | |
| K905789 | FRANKLIN 9000 WALL STAND | KPX | Substantially Equivalent | |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K904146 | NEURO VISION RADIOGRAPHIC X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM | KPR | Substantially Equivalent | |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | IZP | Substantially Equivalent | |
| K902761 | AUTOMATIC CASSETTE LOADER | KPX | Substantially Equivalent | |
| K902446 | DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST | FMW | Substantially Equivalent | |
| K902221 | MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE | DXT | Substantially Equivalent | |
| K901323 | HYDRA VIEW IMAGING SYSTEM | JAA | Substantially Equivalent | |
| K891403 | HUGH YOUNG II UROLOGICAL TABLE | IZZ | Substantially Equivalent | |
| K882329 | L-F COILED EXTENSION TUBING | DXT | Substantially Equivalent | |
| K883312 | L-F/KODAK FLEXIBLE GRID CASSETTE | IXA | Substantially Equivalent | |
| K873687 | ANGIOMAT CT INJECTOR | DXT | Substantially Equivalent | |
| K860204 | ANGIOMAT 6000 | DXT | Substantially Equivalent | |
| K860040 | HYDRAJUST III UROLOGICAL TABLE | KQS | Substantially Equivalent | |
| K781334 | DISPOSABLE SYRINGE FILL TUBE | DXT | Substantially Equivalent | |
| K770836 | ULTIMAT L4 X L4, LIEBEL-FLARSHEIM | KPX | Substantially Equivalent | |
| K760522 | TABLE, UROSURGICAL | KQS | Substantially Equivalent | |
| K760279 | X-RAY FILM, CONVEY OR SYSTEM | KPX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IXACassette, Radiographic Film
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- KPXChanger, Radiographic Film/Cassette
- FMWCover, Mattress (Medical Purposes)
- KKXDrape, Surgical, Antimicrobial
- FYAGown, Surgical
- DXTInjector And Syringe, Angiographic
- IZPProgrammer, Changer, Film/Cassette, Radiographic
- LLZSystem, Image Processing, Radiological
- LJHSystem, Irrigation, Urological
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KPRSystem, X-Ray, Stationary
- KQSTable, Cystometric, Non-Electric And Accessories
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
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