FDA.reportPublic FDA data

OECO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96120753002809480OERTEL MEDICAL GMBH1N2026-01-01OBERE VORSTADT 19-20 TUTTLINGEN Baden-Wurttemberg DE D-78532
30137911803013791180OEB S.R.L.1N2026-01-01Via Circonvallazione, 9 Camposanto Modena IT 41031
30151355403015135540OERTLI INSTRUMENTS, INC.1Y2026-01-012125 Center Avenue Suite 507 Fort Lee NJ US 07024
30316000523031600052OEM DEVELOPMENT1N2026-01-0139 BVD de la romanerie SAINT BARTHELEMY D ANJOU Maine-et-Loire FR 49124
30329128223032912822OECHSLER MEXICO S.A. DE C.V.1N2026-01-01Carretera Estatal 431, km 2+200, Interior 58, Hacienda La Machor Parque Tecnologico Innovacion Santiago de Queretaro MX 76246
12255913000953487Oerlikon AM Medical Inc.1N2020-04-2510 Constitution Blvd S Shelton CT US 06484
30040243723004024372OECANLINK USA INC1Y2020-04-251 passaic st Wood Ridge NJ US 07075

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
399172001164392K972074SUCTION INSTRUMENTATIONGCX1997-07-25
1508171980898082K192760NuVasive Modulus XLIF Interbody SystemMAX2019-10-18
1508171755895799K100757TILOCK PEDICLE SCREW SYSTEMNKB2010-07-01
1508171700577795K080402ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38KWS2008-03-28
1508171872281480K060192APEX KNEE SYSTEMJWH2006-06-15
1508171403859508
399171005446620
399171010307268
399171037778484
3370861052711045
399171069166816
399171074880361
3327271075289715
3370861079867219
3370861088581185
3370861105743901
3370861108645585
399171112527087
399171128207323
3370861135508046
3370861148738122
399171175303012
399171217699289
399171230193800
3370861232984784
399171250800642
399171258645044
3370861271803329
399171299411226
399171309436451
399171316920715
3299451321124921
399171332012032
3370861334171029
399171334714104
399171339867682
399171347825719
399171351528631
399171360837500
3370861364307031
399171371545272
3370861372399958
399171394112601
399171421233952
399171443721751
399171445498641
399171473200514
3370861490215739
3370861526733590
399171528475847
399171552645855
399171567145712
399171571453370
399171576500523
399171578016168
3370861585062890
399171587645446
3370861596303269
3370861607211619
399171611816122
399171625058275
399171625628419
399171625666708
399171629377155
3370861635996071
399171637351698
3370861647982264
399171654279788
399171686803866
399171690429972
399171696686155
399171699967508
3370861701556860
399171728805798
399171733205517
3370861734751110
399171779000681
399171801827357
399171817030332
399171826401573
3370861831761743
399171852422085
399171857164566
3370861866936195
399171867598088
3370861905255414
399171908009339
399171932934398
399171941273704
3370861948847874
399171950636226
399171960511704
399172007155682
399172007768469
3370862012798459
3370862015345406
399172050636836
399172052680846
3370862058096858
3370862059189369
399172069019473
399172072423086

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX12019-10-18
NKB12010-07-01
KWS12008-03-28
JWH12006-06-15
GCX11997-07-25

PMN#

EP 3000

1993-01-04

OEC-DIASONICS, INC.

UROVIEW

1987-07-16

OEC-DIASONICS, INC.