17 results
·
23ms
·
Sources: EU EUDAMED, US FDA
KYPHON (R) HV-R(R) Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526814721·GENUMEDI PSS GREEN O
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239814·
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1504600·Pre-Bent Rod
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L15046015K0·Tap
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L15046013K0·Tap
SunMed
FDA UDI
SUNMED, LLC·20889483042806·CC GUEDEL A/W SZ 60mm PK/10
SMARTLUX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
CPS/OSS 5CM TPR ADAPT W/OSS SC
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·July 14, 2021
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013
SECUREFIT STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code KWY·September 5, 2008
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Malfunction
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·June 7, 2011
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026