20 results
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29ms
·
Sources: EU EUDAMED, US FDA
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIMPLY SPECS
FDA UDI
FGX INTERNATIONAL INC.·00887661073921·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481240·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481257·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481264·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033481233·
MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE STORAGE CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUICK-CORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FCG·September 4, 2018
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 23, 2025
INSET II
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 23, 2025
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JDI·March 8, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 10, 2008
REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KWZ·May 16, 2023
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018