Pall Biomedical Products Co.
Walker, MI, US
Pall Biomedical Products Co. appears in FDA device records in Walker, MI. FDA records list 28 510(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
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Pall Biomedical Products Co. between 1979 and 1997. The busiest year on record is 1984, with 6. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1981 | 2 |
| 1983 | 2 |
| 1984 | 6 |
| 1985 | 5 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | FPB | Substantially Equivalent | |
| K960993 | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | CAK | Substantially Equivalent | |
| K905794 | PALL 3N1 FILTER | FPB | Substantially Equivalent | |
| K902518 | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE | DTM | Substantially Equivalent | |
| K884534 | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER | JPA | Substantially Equivalent | |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | JOD | Substantially Equivalent | |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | KRJ | Substantially Equivalent | |
| K873667 | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | CAK | Substantially Equivalent | |
| K873666 | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | CAK | Substantially Equivalent | |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | JOD | Substantially Equivalent | |
| K853987 | PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE | DTM | Substantially Equivalent | |
| K854062 | PALL PULMONARY FUNCTION FILTER | BZG | Substantially Equivalent | |
| K850826 | POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96 | FPB | Substantially Equivalent | |
| K850825 | AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR | FPB | Substantially Equivalent | |
| K850327 | PALL GAS LINE GUARDIAN FILTER | CAH | Substantially Equivalent | |
| K842141 | SOLUTION CLARIFICATION UNIT | KRJ | Substantially Equivalent | |
| K834382 | PALL EC PLUS FILTER W/FILTER SLEEVE | DTM | Substantially Equivalent | |
| K834380 | PALL EC PLUS FILTER | DTM | Substantially Equivalent | |
| K834381 | POSIDYNE I.V. FILTER/AIR ELIMINATOR | FPB | Substantially Equivalent | |
| K834292 | PALL HEAT MOISTURE EXCHANGING FILTER | BYD | Substantially Equivalent | |
| K840960 | PALL COALESCER | CAH | Substantially Equivalent | |
| K831882 | POSIDYNE SOLUTION CONTAINER FILTER | FPB | Substantially Equivalent | |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | KRJ | Substantially Equivalent | |
| K812505 | PALL ULTIPOR VACUUM LINE BACTERIA FITLER | JQC | Substantially Equivalent | |
| K811985 | ULTIPOR SQ40S BLOOD TRANSFUSION FILTER | CAK | Substantially Equivalent | |
| K791748 | ULTIPOR BLOOD FILTER EXTRA-CORPOREAL | DTM | Substantially Equivalent | |
| K791307 | UNIPOR BREATHING CIRCUIT FILTER | CAH | Substantially Equivalent | |
| K790879 | ULTIPOR SOLUTION CONTAINER FILTER | FPB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- BYDCondenser, Heat And Moisture (Artificial Nose)
- CAHFilter, Bacterial, Breathing-Circuit
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- FPBFilter, Infusion Line
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- CAKMicrofilter, Blood Transfusion
- BZGSpirometer, Diagnostic
- JPASystem, Multipurpose For In Vitro Coagulation Studies
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.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Pall Biomedical Products Co. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Pall Biomedical Products Co.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain