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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DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
FDA 510(k)
FDA Class 2
·Microbiology
Modulus
FDA UDI
Nuvasive, Inc.·00887517992123·Modulus TLIF-A Removal Clip
Arthrex®
FDA UDI
ARTHREX, INC.·00888867554290·One-step dilator, 7.0mm x 265mm
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
PRECISION NOVI?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 9, 2026
SERVICE, CCU, HIGH DEF, 560P, 2NDGEN
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 16, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 19, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012