10 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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ACS 0.02 M CALCIUM CHLORIDE
FDA 510(k)
FDA Class 2
·Hematology
ERA ANGLE 3.25MM IMP MICRO HEAD 13X4MM ACID ETCHED, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549109669·Designed for both transitional and long-term de...
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
FDA 510(k)
FDA Class 2
·Radiology
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·April 28, 2025
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 30, 2014
BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·January 8, 2013
EZ-PRO R4 AMBUL COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FPO·November 12, 2010
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