14 results · 21ms · Sources: EU EUDAMED, US FDA

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TRIA HAIR REMOVAL LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023871·BAYONETTED STRAIGHT RING CURETTE

MOBILE INFANT WARMER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·November 9, 2010

MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME

FDA 510(k)
FDA Class 2 ·Microbiology

AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 2, 2013

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·September 15, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 26, 2011

HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·July 1, 2025

ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

FDA Enforcement
Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018