22 results
·
73ms
·
Sources: EU EUDAMED, US FDA
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
FDA 510(k)
FDA Class 2
·Cardiovascular
CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC·Product code DWF·October 31, 2016
CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWF·April 4, 2016
CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC·Product code DWF·May 10, 2017
CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC·Product code DWF·May 12, 2017
MISTER II
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code FQH·January 12, 2012
RETROGRADE CARDIOPLEGIA CANNULA
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DWF·May 22, 2012
PERICARDIAL SUMP
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DTS·December 18, 2003
STANDARD RIGID TIP SUCTION WAND
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DTS·September 13, 2012
STANDARD RIGID TIP SUCTION WAND
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DTS·September 28, 2012
STANDARD RIGID TIP SUCTION WAND
FDA Adverse Event
Malfunction
·CALIFORNIA MEDICAL LABORATORIES, INC.·Product code DTS·September 28, 2012
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
FDA Enforcement
Class II
·Terminated·California Medical Laboratories Inc·January 16, 2013
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code DWF·November 1, 2018
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
FDA Adverse Event
SORIN GROUP USA·Product code DTS·February 10, 2016
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.
FDA Enforcement
Class II
·Terminated·California Medical Laboratories Inc·January 16, 2013
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
FDA Recall
Terminated
·California Medical Laboratories Inc·Product code DTS·November 2, 2012
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.
FDA Recall
Terminated
·California Medical Laboratories Inc·Product code DTS·November 2, 2012
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
FDA Recall
Terminated
·California Medical Laboratories Inc·Product code DTS·January 24, 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
FDA Recall
Terminated
·California Medical Laboratories Inc·Product code DTS·January 24, 2008