11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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O. B. PACK II
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
STATION,CALL CORD,LIFELINE,9171C
FDA UDI
Crest Healthcare Supply·B48419022720·Station, Call Cord, Lifeline, 9171C
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111876·3M™ Victory Series™ First Molar Bands, 902-272,...
SPACELABS HEALTHCARE
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126864·ABP ONTRAK MONITOR, GERMAN
RANDOX METHADONE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D
FDA 510(k)
FDA Unclassified
·Unknown
EGIA 45 ARTICULATING VAS/MED SULU
FDA Adverse Event
Injury
·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code GDW·June 25, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 15, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
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