25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Prase-C Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003119·Luna Opal MB Mini .018 Kit 3x3 U
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252252047·2.0MP LEFORT I PLATE,5MM ADVANCEMENT,L
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551112198·HALO, 1203-5 VEST MEDIUM, COOLMAX LINER, 1211-1...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112050·Tap, 7.5 mm
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
FDA 510(k)
FDA Class 2
·Radiology
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
MICROWIRE CORTAC®
FDA UDI
PMT CORPORATION·00650551095118·SUBDURAL ELECTRODE, TOP & BOTTOM CONTACTS NUMBE...
WARMER DRAPE
FDA Adverse Event
Malfunction
·MICROTEK DOMINICANA, S.A.·Product code LHC·February 12, 2016
BD DISCARDIT¿ II SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 28, 2023
MICROWIRE CORTAC®
FDA UDI
PMT CORPORATION·00650551095576·SUBDURAL ELECTRODE, TOP & BOTTOM CONTACTS NUMBE...
6 SHOOTER SAEED MULTI-BAND LIGATOR
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code MND·October 20, 2008
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 11, 2011
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 8, 2013
BD MICROLANCE 3 NEEDLES 21G 1 1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·October 19, 2023
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
dS Breast 16ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024