14 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KM Needles (Acupuncture Needle)
FDA 510(k)
FDA Class 2
·General Hospital
BONN SUTURE FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896015760·BONN SUTURE FORCEPS WITH TYING PLATFORM LONG TI...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180523247·DIAGONAL CORNER DRILL GUIDE - THREAD IN, 20MM
HOVEROUND SE-3 POWERCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MICRO-FINE¿ PLUS INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·August 15, 2018
SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 27, 2019
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 3, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014
RADIAL ARTERY PRESSURE MONITORING SET
FDA Adverse Event
Injury
·COOK INC·Product code DQY·June 22, 2011
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 30, 2020
SPYSCOPE DS II ACCESS & DELIVERY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FBN·September 23, 2020
PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018