19 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Modulift Vertebral Body Replacement (VBR) System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694027090·2.0mm X 32mm Cannulated Headless Screw
External Fixation
FDA UDI
Life Spine, Inc.·00190837023096·Male Post, 5 Hole
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10884389005187·CIRCUIT-ADULT ANESTHESIA
LVIS Jr.
FDA UDI
Microvention, Inc.·00842429100820·Stent
LVIS Jr.
FDA UDI
Microvention, Inc.·00810170018992·Stent
LVIS Jr.
FDA UDI
Microvention, Inc.·00812636020150·Stent
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
FDA 510(k)
FDA Class 1
·General Hospital
IGG ANTI-ATHEROX TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694068628·Cannulated 2.0 x 32mm Headless Screw Sterile Qty 5
CELLESTIS
FDA Adverse Event
Malfunction
·CELLESTIS INC.·Product code NCD·February 3, 2016
GMK-HINGE 02.09.2603L FEMORAL COMPONENT #3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·September 23, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
IMPLANT SYSTEM, CPR MINI SCORPION DX
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code GAT·June 19, 2024
BIPAP VISION
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·May 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 31, 2023
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023