Company ยท US
California Medical Laboratories Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2000. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 7, 2000 | K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE California Medical Laboratories, Inc. | DWF |
| Feb 8, 2000 | K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE California Medical Laboratories, Inc. | DWF |
| Sep 30, 1998 | K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc. | DTS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2013 | California Medical Laboratories Inc 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 Terminated |
DTS | K982891 |
| Jan 7, 2013 | California Medical Laboratories Inc Sterile Rigid Tip Suction Wand
The Suction Wands are indicated for use to remove excess fluid from the surgical field. Terminated |
DTS | K982891 |
| Jun 11, 2008 | California Medical Laboratories Inc CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626 Terminated |
DTS | K982891 |
| Jun 11, 2008 | California Medical Laboratories Inc 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 Terminated |
DTS | K982891 |
| Jun 11, 2008 | California Medical Laboratories Inc 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 Terminated |
DTS | K982891 |