18 results
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21ms
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Sources: EU EUDAMED, US FDA
Recon Steerable Sheath
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629746·CoRoent Ant TLIF Ti, 12x11x30mm 12°
BD BBL™ Trypticase™ Soy Agar with 5% SB (TSA II) // Chocolate II Agar
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902213021·Plate Bi TSA II SB & Chocolate II 20 Ea
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205004215·Luna Opal R Mini .022 UR1 (+12°T +5°A)
LiveOne
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·November 26, 2013
STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·November 26, 2013
STERNAL CABLE Ø1 W/NEEDLE+FIXATION SLEEV
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDQ·November 26, 2013
CAPTURE-R READY-SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 24, 2019
EXPEDIUM QC DI EXTENDED TAB POLYAXIAL SCREWDRIVER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HXX·November 3, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·August 24, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 15, 2025
T-PLIF IMPLANT HOLDER
FDA Adverse Event
Injury
·SYNTHES TUTTLINGEN·Product code HTD·December 10, 2014
ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTC·July 30, 2014
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·May 3, 2017
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012