7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMCATH SUCTION-IRRIGATION TUBE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·November 22, 2010
UNKNOWN DEPUY SZ. 28 X 52 LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code KWA·July 1, 2014
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.
FDA Enforcement
Class II
·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024