13 results
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18ms
·
Sources: EU EUDAMED, US FDA
EVACU SLED
FDA 510(k)
FDA Class 1
·General Hospital
ReLine
FDA UDI
Nuvasive, Inc.·00195377069245·RELINE C Screw, 3.5x20mm FA
Fixion Nailing System
FDA UDI
CARBOFIX ORTHOPEDICS LTD·07290109331140·Cortical screw for use with humeral nails
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668110911·SQUEEZE HANDLE CLEANING TUBE
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837015015·
EVA 15 Insufflator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 14, 2023
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Death
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·December 3, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·July 3, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 21, 2012
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015