15 results · 21ms · Sources: EU EUDAMED, US FDA

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Capio SLIM Suture Capturing Device

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B16741720600·

TALOS® IBF

FDA UDI
MEDITECH SPINE, LLC·B1674172060060·

Epimed

FDA UDI
EPIMED INTERNATIONAL, INC·00818788020574·20g TW x 6.0" Coudé® Blunt Nerve Block Needle w...

External Fixation

FDA UDI
Life Spine, Inc.·00190837033934·2.7mm Short Drill

Integra® Miltex®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780360940·Integra® Miltex® Microsurgery Scissors 5-3/4", ...

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100813·FLIERINGA FIXATION RING 20MM

RADIANCE

FDA 510(k)
FDA Class 2 ·Radiology

QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V

FDA 510(k)
FDA Class 2 ·Cardiovascular

2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE

FDA Adverse Event
Malfunction ·SYNTHES SELZACH·Product code HWC·May 19, 2017

AQUILEX FLUID CONTROL SYSTEM

FDA Adverse Event
Malfunction ·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020

ACCU-CHEK ® INFORM II TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 15, 2014

PLUM XLD 110V L.A.

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013

FREESTYLE LITE

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 23, 2008

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

FDA Enforcement
Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025