15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465463·SCREW 7191840 MULTI-AXIAL HA COATED
Sensor Module, Li+
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414484563·Li+ Sensor module, an in vitro diagnostics devi...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741918400·
BLADE HANDLE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896075214·BLADE HANDLE HEXAGONAL
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543641·40mm Cervical Tooth Blade, Wide
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674191840060·
EMERGE FRACTIONAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·June 26, 2013
POWER PRO IT AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·July 29, 2011
ECHELON LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2014
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·December 29, 2023
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024