Ziehm International, Inc.
Riverside, CA, US
Ziehm International, Inc. appears in FDA device records in Riverside, CA. FDA records list 16 510(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
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Ziehm International, Inc. between 1982 and 2001. The busiest year on record is 1982, with 4. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 4 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K011292 | ZIEHM VISION | OWB | Substantially Equivalent | |
| K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR | FMI | Substantially Equivalent | |
| K902196 | MODIFIED STICK-GARD SAFETY NEEDLE | FPA | Substantially Equivalent | |
| K894021 | MOBILE X-RAY UNIT | IZL | Substantially Equivalent | |
| K894041 | PUMP-JECT SYRINGE WITH LUER-LOCK | FRN | Substantially Equivalent | |
| K890620 | STICK-GARD SAFETY NEEDLE | FMI | Substantially Equivalent | |
| K882133 | MAMMO M | IZH | Substantially Equivalent | |
| K843311 | IV ADMIN. SET FOR MVP 1 INFUSION PUMP | FRN | Substantially Equivalent | |
| K842263 | MTP E.V. INFUSION PUMP | FRN | Substantially Equivalent | |
| K831407 | CARDIAC OUTPUT COMPUTER | DXG | Substantially Equivalent | |
| K830453 | IV ADMINISTRATION SETS - MVP INFUSION | FPA | Substantially Equivalent | |
| K830454 | IMS MINIATURE VOLUMETRIC INFUSION PUMP | FRN | Substantially Equivalent | |
| K822003 | BALLOON TEMP. PACING CATHETER | LDF | Substantially Equivalent | |
| K822002 | BIPOLAR TEMP. PACING CATHETER W/STYLETET | LDF | Substantially Equivalent | |
| K822034 | BALLOON WEDGE PRESSURE CATHETER | DYG | Substantially Equivalent | |
| K822033 | BERMAN ANGIOGRAPHIC BALLOON CATHETER | DQO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- LDFElectrode, Pacemaker, Temporary
- OWBInterventional Fluoroscopic X-Ray System
- FMINeedle, Hypodermic, Single Lumen
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- IZHSystem, X-Ray, Mammographic
- IZLSystem, X-Ray, Mobile
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