22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040072639·Steel Bur HP 1/2
Temp Esthetic
FDA UDI
Harvest Dental Products, LLC·D87010039251·Temp Esthetic Disc, 98.5 X 25mm, Shade A3.5
ImmunoFLOW Mycoplasma IgM Positive Control
FDA UDI
GenBio·00613745000091·Mycoplasma IgM Control contains specific IgM ty...
COMFORT
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 11, 2025
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
COOLBLU CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
SYRINGE 1ML LL W/O DN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 25, 2019
NA
FDA UDI
Zimmer, Inc.·00889024067172·
Cable-Ready®
FDA UDI
Zimmer, Inc.·00889024067189·
N/A
FDA UDI
Zimmer, Inc.·00889024067165·
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·December 8, 2008
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 1, 2011
CHILLI II
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code GEH·November 6, 2007
RIA 2 BONE HARVESTING KIT 520MM STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRX·October 6, 2020
RIA 2 BONE HARVESTING KIT 520MM STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRX·October 6, 2020
SYRINGE 1ML LL W/O DN
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 2, 2020
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 2, 2019
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·November 10, 2017