22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
FDA 510(k)
FDA Class 2
·Cardiovascular
Safco EconoPlus 3-ply bibs
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310200283·Safco EconoPlus bib 3ply yllw 500case
A8 INTEGR8® Porous Pedicle Screw System
FDA UDI
ALLUMIN8, INC.·00850080774090·Rod Template, 5.5 mm x 300 mm
Oximeter, Fetal Pulse
FDA Pre-Market Approval
FDA Class 3
·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
ROSA®
FDA UDI
Orthosoft Inc·00889024584419·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410200280·Anterior Closing Wedge Osteotomy Guide, 20mm x ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420200280·Anterior Lateral Closing Wedge Osteotomy Guide,...
RENAFLO II HF 2000 HEMOFILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRAVO PH MONITORING SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
UNKNOWN NATURAL KNEE II FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020
ANEURX ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·March 25, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 9, 2011
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC, USA·Product code LFR·March 27, 2008
UNKNOWN NATURAL KNEE II TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020
UNKNOWN NATURAL KNEE II FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020
UNKNOWN NATURAL KNEE II ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2020
UNKNOWN NATURAL KNEE II FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2020
UNKNOWN NATURAL KNEE II TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 6, 2020
UNK - IMPLANT
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·May 23, 2023
OFFSET CUP REAMER HANDLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 16, 2019