15 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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ABSORBENT ANTIMICROBIAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743618·LEVAMED ANKLE SUPPORT SAND IV
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450616925·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132140·Trial, TLIF, 27L OB CRV 7Deg, 14mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134140·Trial, TLIF, 27L OB STR 7Deg, 14mm
AMEDITECH IMMUTEST DRUG SCREEN COC
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·March 20, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 10, 2011
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 14, 2008
HOMEPUMP C-SERIES 270ML, 10ML/HR
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code MEB·October 9, 2014
HOMEPUMP C-SERIES 270ML, 10 ML/HR
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code MEB·October 9, 2014
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022