101 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·QVCAD SYSTEM
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·QVCAD System (Version 3.3)
Oticon
FDA UDI
Oticon A/S·05707131285416·NERA2 PRO, MINIRITE 312 WL STG
TMA - Archwire
FDA UDI
ORMCO CORPORATION·00889989029574·TMA REV.CURVE/LOOPS 019X025 34MM PK/5
VASER
FDA UDI
SOLTA MEDICAL·00816995021612·ACCESSORY KIT, FAT GRAFTING
P150048
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024
P150048
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025
Transcutaneous Electrical Nerve Stimulators (TENS)
FDA 510(k)
FDA Class 2
·Neurology
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874776·TIBIAL INSERT TRIAL SZ 5 RIGHT MED 10MM
Tibial Cutting Block 0deg
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041335·
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874707·TIBIAL INSERT TRIAL SZ 3 RIGHT MED 11MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874653·TIBIAL INSERT TRIAL SZ 2 RIGHT MED 10MM
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951500431100·Tibial Insert Trial Right Medial Sz 1 10MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874660·TIBIAL INSERT TRIAL SZ 2 RIGHT MED 11MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874837·TIBIAL INSERT TRIAL SZ 6 RIGHT MED 13MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874691·TIBIAL INSERT TRIAL SZ 3 RIGHT MED 10MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556874752·TIBIAL INSERT TRIAL SZ 4 RIGHT MED 13MM
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951500433100·Tibial Insert Trial Right Medial Sz 3 10MM