11 results
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20ms
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Sources: EU EUDAMED, US FDA
embecta Insulin Delivery System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bernafon
FDA UDI
Sbo Hearing A/S·05714464034604·Bernafon EasyControl Connect 3.4.0 Android
CUSA Clarity Ultrasonic Surgical Aspirator System
FDA 510(k)
FDA Unclassified
·Unknown
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MERIT HEMOSTASIS VALVE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEMS, INC.·Product code DQX·August 25, 2011
OPTETRAK HI-FLEX TIBIAL INSERT SZ 4 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·August 12, 2019
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
X3 TRIATHLON CS INS SIZE 4 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·August 29, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 18, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014