California Medical Laboratories, Inc.
Irvine, CA, US
California Medical Laboratories, Inc. appears in FDA device records in Irvine, CA. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for California Medical Laboratories, Inc. between 1998 and 2000. The busiest year on record is 2000, with 2. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE | DWF | Substantially Equivalent | |
| K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE | DWF | Substantially Equivalent | |
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | DTS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0650-2013 | Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field. | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. | Class II | Terminated | |
| Z-0649-2013 | Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field. | California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity. | Class II | Terminated | |
| Z-1177-2008 | CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626 | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. | Terminated | ||
| Z-1176-2008 | CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626 | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. | Terminated | ||
| Z-1175-2008 | CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626 | Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain