18 results
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20ms
·
Sources: EU EUDAMED, US FDA
Endosee System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270473·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513516·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528128190·3.0 X 20mm Cannulated Headed Screw, T10
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
STRYKER SPINE REFLEX TRANSLATIONAL ANTERIOR CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN VANGUARD PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 9, 2018
BIOMET CC CRUCIATE TRAY 67MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·April 19, 2021
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 28, 2011
PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·June 21, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 17, 2014
UNKNOWN BIOMET ARCOM 3-PEG PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD ANTERIOR STABILIZED TIBIAL BEARING 10X63
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
BIOMET CC I-BEAM TIBIAL TRAY 63MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015