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Data / Medical devices / United States / Stellmacher Instruments Inc

Stellmacher Instruments Inc: FDA-registered device maker in Orlando, FL, United States, 7 510(k) clearances

Stellmacher Instruments Inc is registered with the FDA (registration 3029754081) in Orlando, FL, United States. It lists 29 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 16, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Stellmacher Instruments Inc
FDA registration number
3029754081
Address
1271 La Quinta Dr Ste 2, Orlando, FL, United States, 32809
Owner or operator
Stellmacher Instruments Inc (10088967)
Roles
Repackager or relabeler
First device listed
April 6, 2026
Registered through
2026
Brand names listed
11 Pcs Liposuction Cannula Set 30cm, 11 Pcs Liposuction Cannulas Set, 14 Pcs Liposuction Cannulas Set, 17 Pcs Liposuction Cannulas Set, 5 Lachrymal cannula, curved, beveled, 23 ga, ALLIGATOR GRASPING FORCEPS, ASPIRATION HANDLE, AUFRICHT Nasal Retractors Blade 7 x 45, length 18 cm and more

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Repackager or relabeleraccessdata.fda.gov
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Hook, OphthalmicHNQ1Repackager or relabeleraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Repackager or relabeleraccessdata.fda.gov
Marker, ScleraHMQ1Repackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Probe, LachrymalHNL1Repackager or relabeleraccessdata.fda.gov
Punch, Corneo-ScleralHNJ1Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Repackager or relabeleraccessdata.fda.gov
Retractor, OphthalmicHNI1Repackager or relabeleraccessdata.fda.gov
RongeurHTX1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Scissors, OphthalmicHNF1Repackager or relabeleraccessdata.fda.gov
Spatula, OphthalmicHND1Repackager or relabeleraccessdata.fda.gov
Specula, OphthalmicHNC1Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 16, 2024K232355Non absorbable Surgical Silk SutureGAPSubstantially EquivalentShandong Haidike Medical Product Co., Ltd.accessdata.fda.gov
January 8, 2024K233615Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1GEISubstantially EquivalentBaisheng Medical Co., Ltd.accessdata.fda.gov
September 14, 2023K230746Non absorbable Surgical Polypropylene SutureGAWSubstantially EquivalentShandong Haidike Medical Products Co., Ltd.accessdata.fda.gov
August 25, 2023K231183Non absorbable Surgical Polyester SutureGATSubstantially EquivalentShandong Haidike Medical Products Co., Ltd.accessdata.fda.gov
November 23, 2022K221815Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da)GEISubstantially EquivalentBaisheng Medical Co., Ltd.accessdata.fda.gov
December 22, 2021K212603Non Absorbable Surgical Nylon SutureGARSubstantially EquivalentShandong Haidike Medical Product Co., Ltd.accessdata.fda.gov
January 30, 2017K162034OBS Electrosurgical Generator (Model: OBS-350A)GEISubstantially EquivalentBaisheng Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.