18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
FDA 510(k)
FDA Class 2
·General Hospital
CONMED
FDA UDI
Conmed Corporation·10653405000099·SIGMOIDOSCOPIC Suction Instrument, 18 Fr (6 mm,...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033040·Baltic Denture System BDLoad Mm6 PLSEbim6DFm C4...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130400·ROD REDUCER, AXIAL
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
LIGHT SABER INTRODUCER NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WN Octagon plastic coping for 033040, bridge
FDA UDI
BIO CONCEPT Co., Ltd.·06947600302568·
WN Octagon plastic coping for 033040, crown
FDA UDI
BIO CONCEPT Co., Ltd.·06947600302575·
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
CPT 12/14 SIZE 2 COCR EXT
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·August 28, 2018
FEMORAL HEAD +0X22MM DIA
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·August 28, 2018
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 1, 2013
OMNILINK .035 STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·March 29, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LDD·April 22, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024