FDA.reportPublic FDA data

NEXERA MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30379691893037969189NEXERA MEDICAL LLC1N2026-01-019429 Harding Avenue # 293 Surfside FL US 33154
30080107223008010722NEXERA MEDICAL INC1N2020-04-253343 W Commercial Blvd Ste 103 Fort Lauderdale FL US 33309

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3392451641228870K150729SpectraShield 9500 Surgical N95 RespiratorONT2015-12-29
3392451853158230K120244SPECTRASHIELD 9500 SURGICAL N95 RESPIRATORONT2012-07-05
3392451063976972K090414SPECTRASHIELD 9500 SURGICAL MASKONT2011-02-24
1288971161013744K090414SPECTRASHIELD 9500 SURGICAL MASKONT2011-02-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ONT42015-12-29

PMN#