21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
FDA 510(k)
FDA Unclassified
·Unknown
Phaco Tip MST 0.9mm Bent A1 30d
FDA UDI
MICROSURGICAL TECHNOLOGY, INC.·00844685000081·
TLC Uni Knee Meniscal Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077464·
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 15, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2013
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 22, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 22, 2021
INSORB 30 STAPLER
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code GAG·October 12, 2021
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023