13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000790·MCK Onlay Tibia Baseplate
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107163·TRIAL 90-SRK-180616 POLY PS 6X16MM
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197530163·Ferreira Style Breast Retractor
180x16...
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·April 12, 2019
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 9 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·July 20, 2023
BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 8, 2018
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code NIO·October 17, 2014
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·March 9, 2016