22 results · 27ms · Sources: EU EUDAMED, US FDA

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ULTRASOUND SCANNER FLEX FOCUS 1202

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131258847·H15, MINIRITE 312 WL STG

DR COMFORT

FDA UDI
DJO, LLC·00888912235662·Sheer ThighHs OT W 20-30 Nude

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668112236·KIM DOUBLE CHOPPER

BANTAM CATHETER (280MM BALLOON LENGTHS)

FDA 510(k)
FDA Class 2 ·Cardiovascular

MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GENISTRONG

FDA Adverse Event
Malfunction ·GENICON·Product code GCJ·October 15, 2017

PINNACLE 100 ACET CUP 54MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 12, 2013

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 29, 2013

30 INCH TRANSPORT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·June 13, 2011

ADVANCE

FDA Adverse Event
Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 6, 2011

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 6, 2011

132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code FMG·July 31, 2017

132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code FMG·July 31, 2017

132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·September 23, 2025

132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·November 30, 2024