14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Sleepware
FDA UDI
Respironics, Inc.·00606959004849·Sleepware G3 Software Package, English
Sleepware
FDA UDI
Respironics, Inc.·00606959045255·Software, Sleepware G3 (EN)
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
BIOPORTA SOLDER 1020
FDA 510(k)
FDA Class 2
·Dental
THEKEN LARGE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·January 30, 2025
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 29, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 22, 2008
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
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