14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black)
FDA 510(k)
FDA Class 1
·General Hospital
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292855·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049187·K-Wires, Single trocar, .035-inch (0.9mm) diame...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484399·K-Wire w. trocar/round end _x000D_...
K-Wire w. trocar/round end 0.89mm/127mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM711710·K-Wire w. trocar/round end
0.89mm...
VPAP AUTO WITH H3I
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHOVITA PEEK SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·November 21, 2018
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·July 1, 2011
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 14, 2013
TI 5.5 FLEXIBLE ANGLE SCREW 6.0X40
FDA Adverse Event
Injury
·ABBOTT SPINE·Product code KWP·September 22, 2008
PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·August 11, 2020
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·April 3, 2019