12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
FDA 510(k)
FDA Class 2
·Cardiovascular
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607771·STERIS-AMSCO 1080/2080 W/LEG EXTENSION 5" SOFTCARE
STEROTACTIC LOCALIZATION DEVICE (SLD)
FDA 510(k)
FDA Class 2
·Radiology
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL CORPORATION·Product code MVK·April 12, 2013
AU681-02E CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011
LASIK
FDA Adverse Event
Injury
·Product code LZS·July 24, 2008
22 G X 1IN.BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 20, 2017
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 1, 2017
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024