19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEPUT DELTA XTEND REVERSE SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720141·Gruenwald (Jansen) Dressing Forceps 8-1/2" (21c...
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201740·Endoscopy Basic Procedure Kit
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197412094·Knapp iris scissors, straight, sharp
10.5cm
FOUNDATION SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZOLL PROPAQ M
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 7, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 20, 2023
FREESTYLE FREEDOM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·April 14, 2009
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 9, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·September 25, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
COBAS 8000 E 602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 9, 2017
TRUE METRIX
FDA Adverse Event
Injury
·TRIVIDIA HEALTH INC·Product code NBW·November 1, 2022
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·February 12, 2024
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 15, 2009
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015