FDA.reportPublic FDA data

EXACT MEDICAL MANUFACTURING, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30080117793008011779EXACT MEDICAL MANUFACTURING, INC.1Y2026-01-014917 William Street - Suite C Lancaster NY US 14086
30134433043013443304EXACT MEDICAL MANUFACTURING, INC.1N2026-01-0121# Qingjiang Road Changzhou Jiangsu CN 213022

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2041631311901809K222460Intraoperative Ultrasound Probe CoverITX2023-05-12
2041631915724007K211969EMM Ultrasonic Transducer CoverITX2021-08-13
1098461047523152K153025Turbett Surgical ContainerFRG2016-01-14
1098461331716795K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IVKKX2013-02-14
2041631936681212K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IVKKX2013-02-14
1098461365548691K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVFYA2012-06-12
2041631475700633K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IVFYA2012-06-12
1098461157038986K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERFYA2011-08-26
2041631425157293K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYERFYA2011-08-26
2041631276890369K101689EMM EQUIPMENT COVER-POLYTHYLENEKKX2010-09-20
1098461768375302K101689EMM EQUIPMENT COVER-POLYTHYLENEKKX2010-09-20
2041631535178411K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004KKX2010-09-20
1098461594886785K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004KKX2010-09-20
1098461591474752K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)KKX2010-10-04
2041631688632729K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)KKX2010-10-04
1098461297885493K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA2010-09-03
2041632053188335K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA2010-09-03
2041631894833387DEN180008MolecuLight i:XQCR2018-07-31
1098461116099981
1098461370839415
1098461512995950
1098461802038833
1098461827129201
1098461908510253
2041631088644455
2041631175380692
2041631185384310
2041631206194376
2041631239025946
2041631288732891
2041631347516376
2041631376105960
2041631508659185
2041631601023772
2041631813595347
2041631947149290
2041631978945980
2041632002197137

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX82013-02-14
FYA62012-06-12
ITX22023-05-12
QCR12018-07-31
FRG12016-01-14

GUDID#

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