15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578884·CoRoent Ant TLIF Ti, 14x10x32mm 8°
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690110736·Patella Trial 32mm x 8mm
OMNI Knee
FDA UDI
Omni Life Science, Inc.·00841690101956·All Poly 3 Peg Patella 32 mm x 8 mm
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CMC MINI TIGHTROPE
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 9, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 9, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 10, 2014
3MM COARSE DIAMOND BALL, STD
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013
ADHESIVE BANDAGES
FDA Adverse Event
Injury
·KENVUE·Product code KGX·December 18, 2024
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025