25 results
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20ms
·
Sources: EU EUDAMED, US FDA
HITACHI AIRIS II
FDA 510(k)
FDA Class 2
·Radiology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00143341·
TruForm
FDA UDI
Rmo, Inc.·00885797099860·MN 2ND BI BD KT N/L R/L 176
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001334·artVeneer life upper anteriors, BL, C2
3M™ Unitek™
FDA UDI
3m do Brasil Ltda.·00652221002099·Unitek(TM) Twin Torque Curved Bracket U4,5 -7T/...
Threshold V2 Pedicular Fixation System
FDA UDI
SPINEOLOGY INC.·M7401001334·Adjustable Counter Torque
IMPACT MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODEL APS ALTERNANS PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LOW BLEED MODERATE PROFILE ROUND GEL BREAST IMPLANT, 225 CC
FDA Adverse Event
MENTOR CORP.·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
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 27, 2026
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 13, 2015
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·March 6, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 25, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·February 19, 2008
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003 T116430, TLA025-30 TLA025-30, MAC21001 T112972, MAC21001 T13621, TLA025-20 TLA025-20.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016