26 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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HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
FDA 510(k)
FDA Class 2
·Cardiovascular
Sterling C2000
FDA UDI
SKYTRON LLC·10841736121778·C2000L Rack for OP-shoes
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950018581·FORCEP MOSQUITO HALSTED CURVED 7-1/4" 18CM
Ear Sensor
FDA UDI
Honeywell Healthcare Solutions GmbH·04036616009966·Ear Sensor ES-3211-31 MySign® FDA
BetaForce
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730022134·Beta3 Lower 16x16 10 archwires per pack
BetaForce™
FDA UDI
Ortho Organizers, Inc.·00190707124526·BETAFORCE Beta³ Lower 16x16 (10pk)
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018387·Vascular Clamp with spoon Hausmann Jaw
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450180389·
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188652·Battalion, LLIF Trial, 0°, 22 mm Wide, 06 mm X ...
COAPTITE
FDA Adverse Event
Death
·BIOFORM MEDICAL, INC.·Product code LNM·June 20, 2006
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801033322·Lateral Distractors - 20mm taper, 22 x 6
LIFESHIELD ADDITIVE PIERCING PIN
FDA 510(k)
FDA Class 2
·General Hospital
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTEX GENERAL ANESTHESIA CIRCUITS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022
BD DISCARDIT II 2 ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 24, 2020
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·February 11, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011
PRECISE OTW NITINOL STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·February 21, 2008
Interis Allura BiPlane X-Ray System
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAK·July 27, 2005
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012