11 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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PathLoc-L MIS Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
mambo™ modular cervical plate system
FDA UDI
Ulrich GmbH & Co. KG·04052536164394·mambo bone screw, self-drilling, violet, Ø 3.5 ...
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
FDA 510(k)
FDA Class 2
·Immunology
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE FLASH
FDA Adverse Event
Injury
·THERASENSE INC.·Product code LFR·March 17, 2005
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 17, 2014
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code MTA·June 21, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·June 20, 2011
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024