23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLUELEX
FDA 510(k)
FDA Class 2
·Dental
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121173·LOCATOR F-Tx Abutment for Wide Platform (WP) Ex...
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481112898·LOCATOR R-Tx Abutment for Wide Platform (WP) Ex...
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425495146·LACERATION TRAY
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm
OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
FDA 510(k)
FDA Class 2
·Radiology
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
FDA 510(k)
FDA Class 2
·Orthopedic
BACT/ALERT® SN CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·December 26, 2018
BACT/ALERT® SN BLOOD CULTURE BOTTLE
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code MDB·January 10, 2019
25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 21, 2017
ASR XL TAP SLV ADAP 12/14+8
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·April 10, 2013
ICEMAN THERAPY UNIT
FDA Adverse Event
Injury
·DJ ORTHOPEDICS DE MEXICO·Product code ILO·April 6, 2011
PIC
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·May 23, 2008
UNKNOWN TIDISHIELD EYESHIELD
FDA Adverse Event
Malfunction
·TIDI PRODUCTS LLC·Product code LYU·October 14, 2024
HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·May 20, 2022
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·SANMINA -SCI SYSTEMS·Product code OWB·July 18, 2024
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·September 26, 2024
NIM 4.0 CONSOLE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·September 3, 2025
HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·September 20, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
FDA Adverse Event
Malfunction
·HEARTWARE, INC.·Product code DSQ·March 7, 2022