FDA.reportPublic FDA data

NOVAMED-USA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24323201000521377NOVAMED-USA1Y2026-01-014 WESTCHESTER PLZ STE 137 Elmsford NY US 10523

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1073911653714521K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETCCW2007-02-09
1073911891094968K062020LIFESOUND ESOPHAGEAL STETHOSCOPEBZT2006-09-05
1073911140388673K061902COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1DWJ2006-12-08
1073911791276001K051419INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1DWJ2006-04-27
1073911698671969K0222873T/SEWOON TEMPERATURE SENSING FOLEY CATHETERSEZL2002-09-23
1073911362154102K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBEKRI2002-05-03
1073911003155147

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ42006-12-08
CCW22007-02-09
BZT22006-09-05
EZL22002-09-23
KRI22002-05-03