32 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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QUICKIE 2 POWER ASSIST WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6913001491·COMP CORE AF AUTO-CURE TWIST-A3
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105619·PowerChem Neoprene Exam Gloves, Extra Small
GRADIA®
FDA UDI
Gc America Inc.·D0470014911·GRADIA® TRANSLUCENT T2
GRADIA®
FDA UDI
Gc America Inc.·14548161392822·GRADIA® TRANSLUCENT T2
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001491·artVeneer life lower anteriors, UBIS, D3
EliA M2 Positive Control 250
FDA UDI
Phadia AB·07333066020044·EliA M2 Positive Control 250
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494463594·Working Tube Oblique Window
ID 8.5mm, OD 9.5mm,...
BONUS MECHANICAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK FLEXLINK
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 13, 2025
CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2025
Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121. Distributed by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA.
FDA Recall
Terminated
·Medtronic Gastroenterology Urology·Product code FFT·January 25, 2006
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·February 25, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·February 19, 2008
SUMMIT POR TAPER SZ4 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018
SUMMIT POR TAPER SZ6 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018
CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·April 9, 2021