25 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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Viz RV/LV
FDA 510(k)
FDA Class 2
·Radiology
RUSCH
FDA UDI
TELEFLEX INCORPORATED·14026704624659·RUSCH Traditional Guedel Airway Length 100mm Tr...
SPERMCARE Upper Layer - Gradient System
FDA UDI
INVITROCARE, INCORPORATED·00859268006190·SPERMCARE Upper Layer - Gradient System is a 45...
10.5mm CANNULATED ENTRY REAMER
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665032321·
Pomee
FDA UDI
POMEE CORPORATION·G15772211000·Operating scissor straight sharp/sharp
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522211000·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR74802211001·Buccal tube Edgew./Ricketts .022" f. weld. mand...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702602067·Elvarex Forte 3/Thigh High/Slant-Open Toe-Eleph...
Stryker Performance Series
FDA UDI
STRYKER CORPORATION·04546540605665·Stryker Performance Series Sagittal Blade
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
300 PV COMPLETE ELECTROTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
VITEK 2 AST STREPTOCOCUS VANCOMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 28, 2017
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·November 3, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 23, 2011
MAILBU/SOVEREIGN (INCL DIGNITY)
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code ILM·July 5, 2013
BELOTERO BALANCE
FDA Adverse Event
Injury
·ANTEIS S.A.·Product code LMH·May 11, 2021
SIGNA Architect, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025