FDA.reportPublic FDA data

Primo Medical Group, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12229281000120613Primo Medical Group, INC1N2026-01-0175 Mill St STOUGHTON MA US 02072
30094205983009420598Primo Medical Group, Inc1N2026-01-01375 West St W Bridgewater MA US 02379

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1496051150515128K173346LENSAR Laser System - fs 3D (LLS-fs 3D)OOE2018-03-02
1496051354320121K171337LENSAR Laser System – fs 3D (LLS-fs 3D)OOE2017-08-10
131061258411171K170084InterLock TrocarGCJ2017-03-10
1496051480654914K140603ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETMGEI2014-07-31
1496051878029612K120086CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CMDRA2012-04-24
131061341594064K081939OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAYGEX2008-08-12
131061246914435K043346GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00KWS2005-01-31
1496051497076742DEN150029PermasealPNQ2016-07-27
1496051742701331BK130079
131061202617835
131061343225057
131061001666395
1496051008098228
1496051039818848
131061041668737
1496051045379154
131061069621160
1496051070151444
131061072890165
1496051084020921
1496051086731365
1496051086815446
131061089900867
1496051090214631
131061103451231
131061103614396
1496051107601695
1496051109427737
1496051118134399
1496051118458910
1496051124903589
1496051132097846
131061149485603
1496051158610868
131061195436791
131061203661228
131061211940561
131061218561159
1496051232099273
131061238568264
131061244897095
131061246287930
131061266462761
1496051272711849
131061282192343
131061287228907
131061300250427
131061303567576
131061329189320
1496051329491217
1496051346953034
131061346953034
131061353306485
131061355467183
131061357255256
131061370225417
131061380503602
1496051380503602
1496051393014165
1496051401095126
1496051406047427
131061421646507
131061435456764
131061450436932
131061460253618
1496051464837471
131061464837471
1496051469309190
131061472037451
1496051480654914
1496051494947374
131061497778269
131061504635589
1496051504635589
131061517207014
1496051517207014
131061525770063
131061530899003
1496051537008924
1496051549710010
1496051553378178
1496051553689746
131061557560868
1496051557560868
1496051585468614
131061585468614
131061588494145
131061589788776
1496051589788776
131061606928573
1496051643616708
131061643616708
131061646823476
1496051648258098
1496051651671036
131061667866910
131061672160105
1496051681035797
1496051683044305
1496051699408553
1496051714168130
131061730967568
131061737551022
1496051741890832
1496051744645881
1496051746628755
1496051747560726
1496051751801320
1496051766777718
131061777143515
1496051786717891
1496051805554669
131061806082970
1496051806082970
1496051807140432
131061808958333
1496051810246228
131061829149975
131061834276576
131061835112118

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OOE22018-03-02
GCJ12017-03-10
PNQ12016-07-27
GEI12014-07-31
DRA12012-04-24
GEX12008-08-12
KWS12005-01-31