15 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIOLASE ND:YAG DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tornier Latitude
FDA UDI
TORNIER, INC.·00846832015306·ULNAR STEM TRIAL
INUI LENS CO., LTD.
FDA registration
INUI LENS CO., LTD.·3 products·🇯🇵 Japan
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175047·Z-Rod, Dia. 5.5mm, Titanium, 290mm
N/A
FDA UDI
STRYKER CORPORATION·07613327582024·9mm Acorn TPS M
LAZERSMILE, LAZERWHITE
FDA 510(k)
FDA Class 1
·Dental
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROCLAVE
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·July 2, 2015
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 2, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 15, 2008
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016