Tri-Med, Inc.
Kailua, HI, US
Tri-Med, Inc. appears in FDA device records in Kailua, HI. FDA records list 29 510(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
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Tri-Med, Inc. between 1977 and 2004. The busiest year on record is 1981, with 6. The most recent is 2004, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1981 | 6 |
| 1982 | 4 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 3 |
| 1988 | 1 |
| 1996 | 1 |
| 2001 | 1 |
| 2004 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | HRS | Substantially Equivalent | |
| K030877 | TRIMED RADIAL BULLET | HRS | Substantially Equivalent | |
| K010545 | TBW | NDL | Substantially Equivalent | |
| K961863 | PARACENTESIS TRAYS | LRO | Substantially Equivalent | |
| K875224 | HUDSON CRANINAL BURRS | HBE | Substantially Equivalent | |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | CCK | Substantially Equivalent | |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | CCK | Substantially Equivalent | |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | CCK | Substantially Equivalent | |
| K843681 | RESPIRATION & HEART RATE MONITOR 530 | BZQ | Substantially Equivalent | |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | CCK | Substantially Equivalent | |
| K842399 | 48 HOUR SET CHANGES | FPB | Substantially Equivalent | |
| K840248 | IV-FILTER | FPB | Substantially Equivalent | |
| K832093 | FEEDING GASTROSTOMY TUBE | KNT | Substantially Equivalent | |
| K834130 | INTRAVENOUS FILTER SET | FPA | Substantially Equivalent | |
| K833397 | TRI-MED 511 INFANT RESPIRATION MONITOR | CCK | Substantially Equivalent | |
| K831350 | IVFLO-HP & IVFIL-HP FILTER | FPB | Substantially Equivalent | |
| K831315 | TRILEX | FPB | Substantially Equivalent | |
| K823690 | IVFLO-HP & IVFIL-HP | FPB | Substantially Equivalent | |
| K822819 | TRIMED 510 APNEA MONITOR | BZQ | Substantially Equivalent | |
| K820459 | VIRAGARD/VIRASHIELD | DRS | Substantially Equivalent | |
| K812615 | TM-CAPD | KPP | Substantially Equivalent | |
| K813014 | PROTECT-O-SEAL | JOJ | Substantially Equivalent | |
| K813001 | FIBRI-FILTER 20 | FPB | Substantially Equivalent | |
| K812457 | HIFLO-HP | FPB | Substantially Equivalent | |
| K811859 | BACTASHIELD | FIB | Substantially Equivalent | |
| K811981 | ISOLATER THP | KOC | Substantially Equivalent | |
| K811773 | BACTAGARD | FPB | Substantially Equivalent | |
| K790346 | ACTIVATOR | JBP | Substantially Equivalent | |
| K770213 | BARIOR | KOC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- JBPActivated Whole Blood Clotting Time
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- FPBFilter, Infusion Line
- LROGeneral Surgery Tray
- JOJIndicator, Physical/Chemical Sterilization Process
- BZQMonitor, Breathing Frequency
- KPPPeritoneal Dialysate Filter
- NDLPin, Fixation, Smooth, Metallic
- HRSPlate, Fixation, Bone
- FIBProtector, Transducer, Dialysis
- FPASet, Administration, Intravascular
- DRSTransducer, Blood-Pressure, Extravascular
- KNTTubes, Gastrointestinal (And Accessories)
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