14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PASS OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131283603·RIA2, BTE 13 WL 100 SIL
Portex
FDA UDI
ICU MEDICAL, INC.·00351688000890·
Scorpio
FDA UDI
Howmedica Osteonics Corp.·07613154020317·Posterior Stabilized Tibial Insert
KOO AMERICAS VALVE PEEP, MODEL KM-809
FDA 510(k)
FDA Class 2
·Anesthesiology
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
FDA 510(k)
FDA Unclassified
·Unknown
ES2 CANNULATED MODULAR TAP
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code LXH·November 1, 2016
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
PATCH
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·October 8, 2014
UNKNOWN DEPUY ALL POLY TIBIA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 29, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 3, 2008
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 1, 2017