18 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

FIBERGRAFT BG Putty Bone Graft Substitute

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

LOCATOR F-Tx

FDA UDI
Zest Anchors, LLC·00840481121968·LOCATOR F-Tx Abutment For 4.05mm Platform Exter...

Denovo Preformed Matrix Band

FDA UDI
Denovo Dental, Inc.·00810059290860·Denovo Preformed Matrix Band - Pediatric 3/16, ...

PAINT- ON POLISH AGENT

FDA 510(k)
FDA Class 2 ·Dental

KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES

FDA 510(k)
FDA Class 2 ·Cardiovascular

MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK - RIGHT - #6

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

MYKNEE STD FEMUR DISTAL PIN POSITIONER - MRI - GMK SPHERE- LEFT - SIZE6+

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2018

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 14, 2013

ONCOR IMPRESSION PLUS

FDA Adverse Event
Malfunction ·SIEMENS MEDICAL SOLUTIONS·Product code IYE·September 12, 2008

KIT BD MAX EXT ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025