12 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
FDA 510(k)
FDA Class 1
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743755·ACHIMED ACHILLES SUPP SAND VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743632·LEVAMED ANKLE SUPPORT SAND VI
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197541404·RZ Tebbet Breast Retractor
80x16m...
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 24, 2021
DENTO-PREP PARTICLE MICROBLASTER
FDA 510(k)
FDA Class 2
·Dental
SHARP BRAND ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 16, 2015
RESPIRONICS
FDA Adverse Event
Malfunction
·PHILLIPSA·Product code CBK·September 5, 2014
UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 6, 2011
PECTUS TABLE TOP BENDER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HXW·May 14, 2018
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