11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
LAPAROTOMY SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
25M - Heba Fire & Safety
FDA UDI
Certified Safety Manufacturing, Inc.·00766588051352·25M - Heba Fire & Safety
ENZYMUN TEST(R) INSULIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CU-75 VISIBLE LIGHT-CURING UNIT
FDA 510(k)
FDA Class 2
·Dental
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2014
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIO·November 22, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024