19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968738·Pad back section H G
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975828·Trumpf Medical/Medizin Pad back section H G
na
FDA UDI
Ge Medical Systems Information Technologies, Inc.·00840682138024·CABLE ASSEMBLY ECG 3 LEAD NEO AHA LONG
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007514·HANDLE, RATCHETING QUICK-CONNECT
NA
FDA UDI
Ge Medical Systems Information Technologies, Inc.·00840682138048·CABLE ASSEMBLY ECG 3 LEAD NEO IEC LONG
NA
FDA UDI
Ge Medical Systems Information Technologies, Inc.·00840682138031·CABLE ASSEMBLY ECG 3 LEAD NEO IEC SHORT
NA
FDA UDI
Ge Medical Systems Information Technologies, Inc.·00840682138055·CABLE ASSEMBLY ECG 3 LEAD NEO AHA SHORT
JAX GRANULES BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
MEDVIZER PACS, MODEL RELEASE 2000
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
VITROS CHEMISTRY PRODUCTS VALP REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·April 26, 2013
LIGHTSPEED VCT
FDA Adverse Event
Injury
·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011
RELION 1CC INS SYR 31X5/16
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code FMF·July 17, 2008
G7 PPS LTD ACET SHELL 50D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 25, 2025
36MM I.D. SIZE D HIGH WALL LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 26, 2025
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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