22 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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