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

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APEX FIXATION PINS

FDA 510(k)
FDA Class 2 ·Orthopedic

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040014073·Zirlux 16+ C1 98.5X20

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780842·LEVAMED ACTIVE ANKLE SUP SLVR R VI

BLUE MERLIN

FDA UDI
FGX INTERNATIONAL INC.·00193033245484·

CORDIS INTRODUCER GUIDE

FDA 510(k)
FDA Class 2 ·Cardiovascular

RD-3008

FDA 510(k)
FDA Class 2 ·Dental

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016

PATIENT INTERFACE 8253200 RESPONSE 3.0

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·March 14, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·March 8, 2011

QUICKSITE LV

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

CFF03, 5X100 KII FIOS ADVFIX 6/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL·Product code GCJ·September 29, 2015

5.5 EXP VERSE UNITIZED SET SCR

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

5.5 EXP VERSE SCR 6.0X45

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

FDA Recall
Terminated ·Product code HRY·April 22, 2011

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

FDA Enforcement
Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014