26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
FDA 510(k)
FDA Class 2
·Cardiovascular
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143331·
TruForm
FDA UDI
Rmo, Inc.·00885797099853·MN 2ND BI BD KT N/L UNIV 123
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001333·artVeneer life upper anteriors, BXL, C2
3M™ Unitek™
FDA UDI
3m do Brasil Ltda.·00652221002082·Unitek(TM) Twin Torque Curved Bracket U3,4,5 -7...
OptiMesh Multiplanar Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7401001333·3x300mm Stopped ET Ronguer
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGILITY STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
GEL BREAST IMPLANT, 280 CC
FDA Adverse Event
MCGHAN MEDICAL·Product code FTR·March 30, 1994
BIPOLAR MACRO FORCEPS D:5/ 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
BIPOLAR MARYLAND DISS.FCPS 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·March 9, 2015
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 29, 2014
JAW INS. BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG.·Product code GEI·January 13, 2015
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 13, 2015
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
FDA Adverse Event
Injury
·HOLOGIC·Product code MNB·March 6, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 24, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·February 19, 2008
APTIMA SARS-COV-2 ASSAY
FDA Adverse Event
Malfunction
·HOLOGIC INCORPORATED·Product code QJR·June 16, 2022
MARYLAND GSP.FORCEPS FEN.5/310MM HF.CON.
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·August 21, 2015