12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UROLOGICAL GUIDWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
Edge™ Diamond TC014-10M Tapered Chamfer
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172004176·Diamond dental bur, reusable
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704267204·
Crea Calibration Solution 1
FDA UDI
Radiometer Medical ApS·05700699441355·S1827 Crea Calibration Solution 1, membrane bot...
FOUNDATION HYBRID COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRUFILL DCS ORBIT MINI COMPLEX FILL
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code HCG·February 5, 2013
PROXIMATE** SKIN STAPLER 35 WIDE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDT·January 3, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2014
S1827 Crea Calibration solution 1, 944-135, Lot DV-02 Radiometer Medical, Bronshoj Denmark Product Usage: The S1827 Crea Calibration Solution 1 (944-135) Lot DV-02 is a solution used by the ABL 8x7 series creatine analyzers to establish calibration points for measured parameters.
FDA Recall
Terminated
·Radiometer America Inc·Product code CGL·December 16, 2011
PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 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