13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Parcus Twist AP Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304680623·
ZenFlex CM
FDA UDI
Kerr Corporation·10195062145053·.13/.04/21mm ZenFlex CM NiTi FILE REFILL PACK
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304647862·
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GLIDESCOPE CORE 2M QUICKCONNECT CABLE
FDA Adverse Event
Malfunction
·VERATHON MEDICAL ULC·Product code CCW·September 16, 2025
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·May 22, 2019
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2011
T2 STRATOSPHERE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018