20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Axial3D Insight
FDA 510(k)
FDA Class 2
·Radiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021210·FPS 2.7mm x 45mm Locking Screw
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657021784·Strumpel Forceps, straight, 2.5 x 7mm
Sklar®
FDA UDI
SKLAR CORPORATION·10649111189203·LAGRANGE SCI 4 1/2 S SHAP S/S
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071102838·22FR x 2.7 cm x 45 cm Low Profile Transgastric-...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075565·FPS 2.7 x 45mm Locking Screw Sterile Qty 2
Disposable medical face mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071117573·22FR x 2.7 cm x 45 cm Low Profile Transgastric-...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
AGC DA2000 KN TIB BRG 71/75X8
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·April 9, 2026
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·November 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 12, 2013
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·January 22, 2026
VANGUARD ROCC POR FEM S57.5 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·May 13, 2025
TINBN VANGUARD INT PS ANAT FM R 75MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code MBH·June 4, 2025
VANGUARD ROCC POR FEM S55 R
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code MBH·June 4, 2025
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018