13 results · 26ms · Sources: EU EUDAMED, US FDA

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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