13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOPAD
FDA 510(k)
FDA Unclassified
·Unknown
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700587·McGlamry Metatarsal Elevator 6-3/8" (16cm), bla...
THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200
FDA 510(k)
FDA Class 2
·Radiology
BACK-UP MEIER STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 8, 2013
CD HORIZON
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 11, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWP·December 29, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 3, 2013
PATROL PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·February 15, 2011
SET SCREW STAR DRIVER-SHORT
FDA Adverse Event
Injury
·ABBOTT SPINE, INC.·Product code HXX·May 8, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·July 6, 2020
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024