11 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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K-PACK II NEEDLE - 27G X 3/4 THIN WALL
FDA 510(k)
FDA Class 2
·General Hospital
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613070212·Metzenbaum Scissors, TC, Straight, Fine, Blunt ...
COMPREHENSIVE LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019
MEDLEY PCA MODULE, MODEL 8120
FDA 510(k)
FDA Class 2
·General Hospital
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
SELUTE PICOTIP
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVY·October 1, 2014
LAG SCREW, TI GAMMA3 Ø10.5X95MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·May 29, 2013
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·June 14, 2011
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021