14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAMANT ZIRCONIA DISC
FDA 510(k)
FDA Class 2
·Dental
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481137853·LOCATOR R-Tx Attachment System for Hiossen Impl...
Tungsten Carbide Burr
FDA UDI
ELLIQUENCE, LLC·00846338002763·
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
FDA 510(k)
FDA Class 2
·Cardiovascular
ONE TOUCH BASIC ENHANCED
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·April 22, 2002
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 7, 2021
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013
HUDSON MICRO MIST NEBULIZER W/TEE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·June 2, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·June 8, 2016
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018