10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OSMOMETER MODEL OM-6010
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AURADONICS
FDA UDI
AURADONICS INC.·00810033836169·LATEX ELASTICS 3/8" 2.5 oz. - NEON, 50 bags of ...
DELDENT ULTRASONIC INSERTS
FDA 510(k)
FDA Class 2
·Dental
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
FDA 510(k)
FDA Class 2
·Dental
CLAVE IV BAD ACCESS DEVICE
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·July 9, 2014
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·August 9, 2010
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE
FDA Adverse Event
Malfunction
·CONMED CORPORATION·Product code MBI·April 23, 2019
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018