14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIRAscore
FDA 510(k)
FDA Class 2
·Radiology
XLIF
FDA UDI
Nuvasive, Inc.·00887517191687·XLIF Blade, 180mm Lung Retractor Narrow
Suede Thumb Support
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357231805·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114087·SIMCOE CORTEX EXTRACTOR (PK/10)
TriVerse Asymmetric Patella Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215097615·
FALCON SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 4, 2018
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAB
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 31, 2018
COULTER LH750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·August 12, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018