10 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPOC BLOOD ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040128029·STAINLESS STEEL STRAIGHT WIRE 14 .020 ROUND
SMARTMONITOR 2, MODEL 4000
FDA 510(k)
FDA Class 2
·Anesthesiology
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCREW SD 3.5X12MM
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code ODP·April 11, 2013
AXSYM RUBELLA IGG ANTIBODY
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code LFX·June 17, 2008
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 18, 2011
cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018
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