73 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PBN FALLOPIAN TUBE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Implant Prosthetics
FDA UDI
Preat Corporation·00842092117347·NobelBiocare™ Tri-Lobe-compatible WP Engaging G...
N/A
FDA UDI
Ortho Development Corporation·00822409090495·Alpine Reamer Size 20
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082051852·APEX Uniplanar Screws Case -Case and Lid Only-
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132119679·ø2.0mm x 300mm Round Tip Flexible IM Nail
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082051876·Uniplanar 2 Screw Caddy
APEX Spine System
FDA UDI
SPINECRAFT, LLC·00193082051869·Uniplanar 1 Screw Caddy
APEX-DL Spine System
FDA UDI
SPINECRAFT, LLC·00193082052118·APEX-DL Uniplanar Screws Case -Case and Lid Only-
PRO-TORQ
FDA 510(k)
FDA Class 1
·Dental
MODIFICATION TO ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Midmark
FDA UDI
MIDMARK CORPORATION·00841709105869·IQvitals Zone, non-Wireless, with Serenity BP a...
APEX-DL Spine System
FDA UDI
SPINECRAFT, LLC·00193082052132·Uniplanar DL Screw Caddy 2
APEX-DL Spine System
FDA UDI
SPINECRAFT, LLC·00193082052125·Uniplanar DL Screw Caddy 1
PedFlex Flexible Nailing System
FDA UDI
ORTHOPEDIATRICS CORP.·00841132198346·Ø2.0 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·August 10, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 23, 2025
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 12, 2013
DURA STAR RX PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·February 24, 2011
PRECISION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORP.·Product code LGW·February 21, 2008
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
FDA Recall
Open, Classified
·Product code FMF·May 12, 2025