19 results · 23ms · Sources: EU EUDAMED, 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