ONY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10436531043653ONYX MEDICAL LLC1N2026-01-011800 North Shelby Oaks Drive MEMPHIS TN US 38134
13190861319086ONY BIOTECH INC.1N2026-01-01455 Commerce Dr Amherst NY US 14228
20252912025291ONYX INDUSTRIES, INC.1N2026-01-01521 W Rosecrans Ave GARDENA CA US 90248
30102093653010209365ONYX HEALTHCARE USA, INC.1N2026-01-01324 W Blueridge Ave Orange CA US 92865
29515571000307124ONYX MEDICAL INC.1Y2020-04-2516 Digital Drive Suite 120 Novato CA US 94949

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1570991715002179K112718NUVASIVE NVM5 SYSTEMETN2012-03-16
498331757643146K101901IPL THERAPY SYSTEMONF2011-03-08
498332039138809K083590ISKRA MEDICAL GREEN IRF PRESTIGEGEI2009-04-17
498331229345161K050950MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMSGEX2005-04-29
498331381827398
498331595369090
439431003011481
439431003559871
439431027347761
50461030740665
439431033867463
439431036929910
439431043467565
439431049004114
439431055845959
439431058592086
439431065108971
439431065505307
439431068631588
439431070900008
439431077190462
439431080740570
439431084556758
439431105977315
439431107044818
439431117703384
439431118289765
439431132115210
439431147786494
439431149268844
439431150025132
439431152544183
439431154564977
439431159522573
439431162745046
439431174954304
439431180127316
439431184710376
439431187171745
439431204700255
50461211456352
439431215244242
439431215491216
439431221359397
439431241031948
439431255202851
439431267437227
439431283080627
439431284884205
439431293145551
439431303330292
439431313674827
439431319411327
439431323486998
439431352218249
439431352571044
439431361125169
439431368025853
439431369433408
439431370935868
439431371965740
50461374051618
439431374633078
439431378491066
439431381593249
439431387350126
439431393810321
439431395417134
439431396819102
439431419966931
439431445320738
439431449700358
439431450108134
439431460889033
439431465256148
439431466739711
439431467304055
439431470729282
439431471292981
439431473067497
439431477932801
439431481468862
439431492178042
439431497539280
439431498019572
439431506273935
439431516208974
439431520845680
439431528013498
439431528901740
439431544743790
439431544786318
439431545128622
439431549227566
439431563510918
439431567777060
439431578154819
3366541581879162
439431582540975
439431588101462
439431590600752
439431590969330
439431594459770
439431595983539
439431600422299
439431600422885
439431601901932
439431607540858
439431632855074
439431637862866
439431639745492
439431655768234
439431663774491
439431664825951
439431669289183
439431670425166
439431685555760
439431691629643
439431692097332
439431694626784

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ETN12012-03-16
ONF12011-03-08
GEI12009-04-17
GEX12005-04-29

NDC#

KYPROLIS

Onyx Pharmaceuticals, Inc.

carfilzomib

KYPROLIS

Onyx Pharmaceuticals, Inc.

carfilzomib

KYPROLIS

Onyx Pharmaceuticals, Inc.

carfilzomib

PMN#

T-PLATE

1994-05-04

ONYX MEDICAL CORP.

K-WIRE

1990-07-30

ONYX MEDICAL CORP.

48 records. Showing 1-40. Next

Applications#