22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SANICLAVE 200
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799387·MANUMED ACTIVE WRIST LEFT SAND XS
ALIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837080136·
28mm x 11mm x 11mm Oblique with Inserter
FDA UDI
XENCO MEDICAL LLC·B064XM01128111·28mm x 11mm x 11mm Straight TLIF with Inserter
28mm x 11mm x 11mm Straight Titanium TLIF with Inserter and Tamp
FDA UDI
XENCO MEDICAL LLC·B064XMTL1112811·
28mm x 11mm x 11mm Straight Titanium TLIF with Inserter and Tamp
FDA UDI
XENCO MEDICAL LLC·B064XMTL11128111·
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AOS ORION IR-192 SOURCE CABLE
FDA 510(k)
FDA Class 2
·Radiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
MBT CEM KEEL TIB TRAY SZ4
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·May 18, 2011
HEARTSTRING III SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 24, 2024
HEARTSTRING III SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·October 7, 2024
HEARTSTRING III SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 4, 2024
HST III SYSTEM (4.3MM)
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·December 9, 2024
HEARTSTRING III SYSTEM 4.3MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·October 4, 2024
HEARTSTRING III SYSTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code DXC·November 12, 2024
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc.·October 22, 2025
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Alcon Custom Ophthalmic Surgical Procedure Packs
FDA Enforcement
Class II
·Terminated·Alcon Research, LLC·April 7, 2021