21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Affordable
FDA UDI
Keystone Industries·H66810142301·Pour Powder Lt. Fib Orig 1 lb
VaPro Pocket
FDA UDI
HOLLISTER INCORPORATED·00610075052981·No Touch Urethral Intermittent Catheter, Hydrop...
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573785·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573761·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573808·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573754·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573792·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033573778·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0142100·Trial, TLIF, 32L OB CRV 7Deg, 10mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHEM-ALERT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·March 12, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·March 10, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 18, 2014
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·April 13, 2018
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
FDA Enforcement
Class III
·Terminated·DeVilbiss Healthcare LLC·July 9, 2014