15 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033094·Baltic Denture System BDLoad Mw6 PLSEbim6DFm D3...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707037642·45mm PALATAL BAR
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
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
ORTHOSONIX ENERGEX
FDA 510(k)
FDA Class 2
·Physical Medicine
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 21, 2015
VELA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·February 19, 2015
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
1288 CCU INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FWB·February 28, 2011
UNK DEPUY SCREW
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·April 22, 2008
EMBRYO RPLCMNT CATHETER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019
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