13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
FDA 510(k)
FDA Class 2
·Hematology
AOSCAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 65mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665021011·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036025939·
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 13, 2025
CG+ PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·September 25, 2016
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 16, 2013
VERSYS HIP SYSTEM FEMORAL STEM FIBER METAL TAPER COLLARLESS NECK TAPER W/ CALCIC
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWY·June 13, 2008
COBAS C111
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CGA·April 18, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015