13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ULTRAZYME PLUS CKI, #64978,65027&65028
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Deltaven Fast Flash
FDA UDI
DELTA MED SPA·08032248382145·Safety IV catheter in PUR with closed system, d...
Invenio
FDA UDI
Gri-Alleset, Inc.·00840365900092·Cohen Endovenous Pack Healthworx
STRADIS HEALTHCARE
FDA UDI
STRADIS MEDICAL, LLC·M75268214730·CUSTOM SURGICAL KIT, ENDOVENOUS PACK
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268214731·CUSTOM SURGICAL KIT, ENDOVENOUS PACK
Flowart
FDA 510(k)
FDA Class 2
·General Hospital
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MONOMAX VIOLET 1 (4) 150CM HRT48 LOOP (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL S.A.·Product code NWJ·January 15, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·October 24, 2012
VASOVIEW 7 XB DISSECTION TIP
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 24, 2010
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015