17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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 SÃ RL CH·Product code NKB·December 19, 2019
5.5 EXP VERSE SCR 6.0X45
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL 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