13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COALESCENT SURGICAL U-CLIP AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Extend Frame system
FDA UDI
Elekta Instrument AB·07340048304580·DENTAL KIT ZHERMACK
RVG 6100
FDA UDI
CARESTREAM HEALTH, INC.·60889978024360·6100 Size 2 Upgrade
OneTouch Ultra Plus Flex
FDA UDI
LifeScan Europe GmbH·00353885012836·OneTouch Ultra Plus Flex™ Blood Glucose Monitor...
MAC-LAB/CARDIOLAB EP/COMBOLAB
FDA 510(k)
FDA Class 2
·Cardiovascular
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEVICE 8252410 NIM-NEURO 2.0 INTERFACE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 27, 2013
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 19, 2011
SHILEY DCT
FDA Adverse Event
Injury
·HENEQUEN·Product code BTO·April 2, 2008
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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