19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Single Use Balloon Dilator V (with Knife)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AGXO
FDA UDI
Oticon A/S·05707131284853·H150V2, MINIRITE 312 WL TC AGXO
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197540339·Caspar Rongeur downwards angled 2x12mm 1
40mm
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
RESMED MERIDIAN MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
ARCHITECT I2000SR ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJE·November 4, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 30, 2020
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 19, 2023
AMISTEM H CEMENTLESS STEM SIZE 3 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 22, 2015
TECNIS 1-PIECE
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·October 7, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 6, 2013
HAEMOLANCE LANCET
FDA Adverse Event
Injury
·HTL-STREFA S.A.·Product code FMK·October 3, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 27, 2023
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 19, 2023
COBAS 8000 COBAS ISE MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·October 2, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024