11 results
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18ms
·
Sources: EU EUDAMED, US FDA
STOMACH, GASTRO-ENTEROSTOMY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080376·DOWEL 902-421 20MM ADJUSTER
ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CANDELA MID IR DIODE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3.0 x 42CM HI-RES GALILEAN LOUPE - 902421
Device
EU MDR
·
Eu Md Class 1
·Keeler Ltd·On the market·1 country
SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·July 9, 2015
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Other
·STRYKER CORP, MEDICAL DIV·Product code INK·November 12, 2010
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012