15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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McKesson Radiology Mammography Plus
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105283·CASTROVIEJO SCISSORS ANGLED MEDIUM
BD MICRO¿FINE+ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 8, 2018
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
G7 NEUTRAL E1 LINER 32MM D
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·March 27, 2018
BD¿ INSULIN SYRINGE U40
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·June 25, 2018
BD MICRO¿FINE+ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·June 27, 2018
INDIGO SYSTEM ASPIRATION CATHETER
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code QEW·August 7, 2023
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2014
UNKNOWN DEPUY SUMMIT FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LWJ·June 23, 2011
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·February 22, 2019
INDIGO SYSTEM ASPIRATION CATHETER D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DXE·September 5, 2017
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022