30 results
·
21ms
·
Sources: EU EUDAMED, US FDA
COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Neurology
NexxZr™ / W-98-16-UT-B300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271138996·
ARGESOL 690PF STRIP
FDA UDI
ARGEN CORPORATION, THE·D818103081·Gold based noble metal
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·May 12, 2022
ACCU-CHEK ® GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·May 13, 2022
ENTEROSCOPY OVERTUBE, MODEL 00712140
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDSTAR 150
FDA 510(k)
FDA Class 2
·Physical Medicine
Widex
FDA UDI
Widex A/S·05706069327120·Widex mind440 M4-m BTE (Tan silk ) Switch
Widex
FDA UDI
Widex A/S·05706069370157·Widex mind220 M2-m BTE (Tan silk ) Switch
Widex
FDA UDI
Widex A/S·05706069326949·Widex mind440 M4-9 BTE (Tan silk ) Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069328363·Widex mind330 M3-9 BTE (Tan silk ) Telecoil, RC...
Widex
FDA UDI
Widex A/S·05706069328127·Widex mind330 M3-m BTE (Tan silk ) Switch
MEGA SUTURECUT NEEDLE DRIVERINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 9, 2013
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·September 19, 2014
PROLIFT +M PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON·Product code FTL·May 25, 2011
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 18, 2022
ROI-C SHORT ANCHORING PLATE
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code OVE·June 24, 2025
IV SET BN306 W/O BP 200C
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·June 7, 2021
Medical Linear Accelerator
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·July 8, 2016
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014