16 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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LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033924·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR300
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001372·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
AUTOCON II 200 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAVIDON MEDICAL ELECTRODE JELLY
FDA 510(k)
FDA Class 2
·Neurology
R90 SPACERS
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009
R90 SPACERS
FDA Adverse Event
Other
·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009
R90 SPACERS
FDA Adverse Event
Injury
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·April 3, 2013
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 23, 2011
PFC KEEL TIB TRAY CEM SZ3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 24, 2008
R90 SPACER
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013