11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
FDA 510(k)
FDA Class 2
·Physical Medicine
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191441101·IN-OVATION® mini Base Rx 018/LL4-17T -1A 4D HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191441001·IN-OVATION® mini Base Rx 018/LL4-17T -1A 4D
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191441811·IN-OVATION® mini EURO 018/LL4 -12T 2A HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191441801·IN-OVATION® mini EURO 018/LL4 -12T 2A
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
FDA 510(k)
FDA Class 2
·General Hospital
UNIMAX VERESS NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SCORPIO NRG INSERT TRIAL #7 8MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·July 28, 2011
APPLICATOR KNOB
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·June 26, 2013
PRECISION SPECTRA®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 22, 2014
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023