12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoolSculpting Elite System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252096023·LeFort I Plate, 7mm advancement, right
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837067243·Custom Small Anatomical Spacer, 7degree, 7mm
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ESTENIA
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2008
JETSTREAM G3
FDA Adverse Event
Injury
·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·August 11, 2011
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 9, 2013
HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
FDA Enforcement
Class II
·Terminated·HemoCue AB·November 6, 2013
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021