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

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15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NITI-S BILIARY STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SAPPHIRE ST PORTABLE DIODE LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

BALL HEADS: COCR BALL HEAD 12/14 Ø 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 6, 2024

NX3

FDA Adverse Event
Injury ·KERR CORPORATION·Product code EMA·June 17, 2013

ALTRUA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011

FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·September 25, 2008

MPACT DOUBLE MOBILITY ACETABULAR SHELL 52

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·August 25, 2021

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·September 19, 2019

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018