FDA.reportPublic FDA data

ABLE MEDICAL DEVICES

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146807953014680795ABLE MEDICAL DEVICES1Y2026-01-01512 Fourth Street Gwinn MI US 49841
30387765933038776593Able Medical Devices1N2026-01-012812 Beecher Street Marquette MI US 49855

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2206371726125353K232515Valkyrie Thoracic Fixation SystemHRS2023-12-08
3408531726125353K232515Valkyrie Thoracic Fixation SystemHRS2023-12-08
2206371870802596K211695Valkyrie Thoracic Fixation SystemHRS2021-06-23
3408531870802596K211695Valkyrie Thoracic Fixation SystemHRS2021-06-23
2206371800776941K202889Able Medical Devices Valkyrie Thoracic Fixation SystemHRS2021-03-02
3408531800776941K202889Able Medical Devices Valkyrie Thoracic Fixation SystemHRS2021-03-02
2206372018680884K190359Sonendo GentleWave SystemELC2019-03-16
2206371019090862
2206371074565695
2206371516840088
2206371847448021
2206371867368448
2206371993670644
2206372008975153
2206371016516723
2206371022426066
2206371022572950
2206371034129829
2206371043923819
2206371047958442
2206371051236728
2206371051289306
2206371082553621
2206371097618791
2206371106760380
2206371124180731
2206371126154360
3408531126154360
2206371136759219
2206371148879939
2206371153618817
2206371192517379
2206371192746205
2206371211436159
2206371262931117
2206371264907549
2206371280345466
2206371291481545
2206371292537513
2206371294297005
2206371361182701
2206371375277403
2206371401456523
3408531401456523
2206371453306038
2206371457303873
2206371473354440
2206371474817999
2206371482389552
2206371483223512
3408531483223512
2206371507497716
2206371508069652
2206371529301277
2206371539169044
2206371541415050
2206371550950402
2206371551780858
2206371563401746
2206371568887320
2206371569864284
2206371594149821
2206371600876084
2206371605633899
2206371608699845
2206371629063364
2206371633538652
2206371639049470
3408531639049470
2206371661803301
2206371670608846
2206371674599564
3408531674599564
2206371681006193
2206371688891982
2206371698107231
2206371710152702
2206371710559189
2206371717306325
2206371734177656
2206371779443492
2206371782534451
2206371797832235
2206371806163729
3408531806163729
2206371814547946
2206371823245785
2206371836605277
3408531847448021
2206371850335111
2206371870824470
2206371887209588
2206371890926476
2206371903505841
2206371913188035
2206371930089071
2206371930931045
2206371953351145
2206371963213437
2206371977612277
2206371978227207
2206371994779852
3408532008975153
2206372013342200
2206372020580377
2206372022303763
2206372026572540
2206372034973845
2206372054003441
3408532054003441
2206372067128136
2206372072163083

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS62023-12-08
ELC12019-03-16