16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
FDA 510(k)
FDA Class 2
·Dental
S.G. Calibrator H
FDA UDI
ARKRAY USA, INC.·04987486053002·The S.G. Calibrator H is used for calibration o...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033528·Coupling Treatment Tube for 4F Flexibles (19)
StaXx® XD System
FDA UDI
Spine Wave, Inc.·10840642100259·Cartridge Convex Expandable Implant Ti 25x9x7mm
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMERITEK BRACHYTHERAPY TEMPLATE
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·December 1, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
IN TOUCH EU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·September 23, 2014
AML 10.5 MMA 6.3 5/8 STD 12/14
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 13, 2011
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·May 21, 2009
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021