23 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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E1 ANTIOXIDANT INFUSED TECHNOLOGY
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166183728·RASP, 12mm
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828114264·GEN4 INTERACTIVE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694001380·12mm Chin Plate
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 48mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665037142·
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828161848·GEN4 INTERACTIVE
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828136723·GEN4 INTERACTIVE
Pediatric BP Cuff (small/child) 17-25cm
FDA UDI
VASOMEDICAL, INC.·00817980020672·Pediatric BP Cuff (small/child) 17-25cm
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·February 8, 2024
OsteoMed
FDA UDI
OSTEOMED LLC·00845694063180·2.0 System 12mm Chin Plate Sterile Qty 2
SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
FDA 510(k)
FDA Class 2
·General Hospital
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
MEGA 8FR. 50CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·January 2, 2024
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·September 18, 2014
MP70 INTELLIVUE PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·May 16, 2011
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Recall
Terminated
·Anjon Holdings·Product code JEC·June 18, 2020
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Enforcement
Class II
·Terminated·Anjon Holdings·August 19, 2020