16 results · 23ms · Sources: EU EUDAMED, US FDA

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ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

TruLock

FDA UDI
Rmo, Inc.·00885797644893·TRULOCK Light Activated Adhesive Kit (40 Capsule)

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196440·AK3 Ultra Tibial Insert Trials Size 1 - 5 Pan

Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)

FDA UDI
Promepla·03700512901860·2 spikes - pump segment

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690195153·AK3 Ultra Tibial Insert Trials Size 1 - 5 Pan I...

VIRIDIS DERMA LASER

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

SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 15, 2014

LIVER ACCESS AND BIOPSY SET

FDA Adverse Event
Injury ·COOK, INC.·Product code FCG·May 5, 2011

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·April 25, 2023

HANDPIECE MICS

FDA Adverse Event
Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 3, 2018

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

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