11 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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INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848779·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776098407·Adson Cerebellum Retractor
ABN ANEROID SPHYGMOMANOMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
FDA 510(k)
FDA Class 2
·Radiology
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
KINETRA
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MHY·April 11, 2013
THERMATRX OFFICE THERMO THERAPY SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MEQ·March 15, 2011
VITROS 5, 1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·May 21, 2008
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 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