35 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach
FDA 510(k)
FDA Class 2
·Cardiovascular
Kleiner KG2 system
FDA UDI
Baat Medical Products B.V.·08720246783049·Trial
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169497481·ASSY 25121-1 DELTA SML SNAP PERIT 120
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00763000030575·ASSY 25121-1 DELTA SML SNAP PERIT 120
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312512110·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322512110·
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00810065990679·Squadron Anatomical Bullet Nose PLIF Cage, 25mm...
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00811771037597·Squadron Lordotic Bullet Nose PLIF Cage, 25mm x...
Squadron Lumbar Cage
FDA UDI
VALORUS SPINE LLC·00811771035791·Squadron Parallel Bullet Nose PLIF Cage, 25mm x...
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
LOQTEQ®
FDA UDI
aap Implantate AG·04042409363139·LOQTEQ® VA Volar Distal Radius Plate 2.5, narro...
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 16, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY AG·Product code MTA·November 14, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 29, 2013
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-135-01 / 989930004171 / 2.3 mm OTW 423-135-02 / 989930004181 / 2.3 mm OTW 425-135-01 / 989930004201 / 2.5 mm OTW 425-135-02 / 989930004211 / 2.5 mm OTW The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
FDA Enforcement
Class II
·Ongoing·Spectranetics Corporation·December 25, 2024