23 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814732·GENUMEDI EXTRA WIDE SAND SIZE V
K2M General Instruments
FDA UDI
VB Spine LLC·10888857520554·Split Tube Retractor, Size Ø18x70 mm
GLOBAL HEALTHCARE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JAS MAGNESIUM REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AGX
FDA UDI
Widex A/S·05706069748345·Audigy AGXWU-FM (Midnight black S-220 ) RC coil
AGX
FDA UDI
Widex A/S·05706069749199·Audigy AGXWU-FP (Midnight black S-220 ) Telecoi...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2025
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·May 10, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 24, 2011
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 12, 2021
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 4MM X 7CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
GALAXY G3 XSFT 3.5MM X 7.5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·June 15, 2022
GALAXY G3 XSFT 2MM X 2CM
FDA Adverse Event
Injury
·CERENOVUS, INC.·Product code KRD·July 7, 2023
STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 7, 2022
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare·September 25, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023