17 results
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20ms
·
Sources: EU EUDAMED, US FDA
STIMULATOR, NIC-106 VISUAL
FDA 510(k)
FDA Class 2
·Neurology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809916490248·MIS Fenestrated Screw M, Ø10.5 x 70mm, Ø6.0mm Rod
STAINLESS STEEL CABLE/SLEEVE COMBO
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDQ·July 24, 2017
RANAWAT/BURSTEIN ACETABULAR SHELL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 24, 2017
TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 24, 2017
RINCLOC AND QUICK CONNECT DRILL BIT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HTW·July 24, 2017
RING LOC ACETABULAR LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 24, 2017
COLLARLESS BI-METRIC POROUS STEM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·July 24, 2017
MODULAR HEAD COMPONENT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 24, 2017
CALCIUM/MAGNESIUM ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROBINSON MIDDLE EAR PROSTHESIS
FDA 510(k)
FDA Class 1
·Dental
SECURA VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·December 31, 2013
ICON 25 HCG (COMBO CASSETTE)
FDA Adverse Event
Other
·BIOSITE INCORPORATED·Product code JHI·August 2, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018