Bemis Health Care
Mchenry, IL, US
Bemis Health Care appears in FDA device records in Mchenry, IL. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Bemis Health Care between 1976 and 1989. The busiest year on record is 1976, with 5. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 3 |
| 1981 | 1 |
| 1982 | 2 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K885019 | BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. | FRG | Substantially Equivalent | |
| K822557 | SPECIMEN ADAPTOR | BYZ | Substantially Equivalent | |
| K822556 | CRITICAL MEASUREMENT UNIT | BYZ | Substantially Equivalent | |
| K803206 | SUCTION PROBE | JOL | Substantially Equivalent | |
| K771737 | SUCTION CANISTER | GCX | Substantially Equivalent | |
| K771738 | MALE URINAL | FNP | Substantially Equivalent | |
| K771733 | 8 EMESIS BASIN | FNY | Substantially Equivalent | |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | FOB | Substantially Equivalent | |
| K760073 | BASIN, WASH, 6-QT RECTANGULAR | LDQ | Substantially Equivalent | |
| K760072 | CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR | Substantially Equivalent | ||
| K760071 | TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 | Substantially Equivalent | ||
| K760070 | TUMBLER, PERSONAL, ROUND, 9 OUNCE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0170-2007 | 5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI. | The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain