13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRONTO .035 EXTRACTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004035·PowerChem Neoprene Exam Gloves, Medium
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694307·Pilot Guided Sleeve Ø2mm L5mm, L25mm Drill (Pur...
StrykeFlow
FDA UDI
STRYKER CORPORATION·07613327051742·Reusable Suction Irrigation Tip, Standard, Vent...
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
FDA 510(k)
FDA Class 2
·Orthopedic
STELLARIS 23G VITRECTOMY CUTTER
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 17, 2013
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD·Product code BTR·April 18, 2011
BD PARADIGM LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP.·Product code NBW·July 3, 2008
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·May 15, 2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·May 15, 2013
Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.
FDA Recall
Terminated
·Midmark Corp·Product code FLE·March 5, 2003