18 results · 23ms · Sources: EU EUDAMED, US FDA

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LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450210475·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450204245·

K991088

FDA Adverse Event
Malfunction ·BD CARIBE LTD.·Product code JKA·September 27, 2018

ULTRASIM CT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SIII ALARM AMPLIFIER

FDA 510(k)
FDA Class 2 ·Cardiovascular

PINN MAR NEUT 28IDX48OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·September 21, 2015

PANORAMA CENTRAL STATION

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·August 14, 2013

LL VLV ADPT(STAND ALONE)

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 17, 2020

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

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