Data / Medical devices / United States / Endomed, LLC
Endomed, LLC: FDA-registered device maker in Orlando, FL, United States, 13 510(k) clearances
Endomed, LLC is registered with the FDA (registration 3016248634) in Orlando, FL, United States. It lists 37 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016248634
- Address
- 3505 Lake Lynda Dr Suite 200, Orlando, FL, United States, 32817
- Owner or operator
- EndoMed, LLC (10062249)
- Roles
- Complaint file establishment, Manufacturer for export, Repackager or relabeler
- First device listed
- January 2, 2020
- Registered through
- 2026
- Brand names listed
- Endomed
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Applier, Hemostatic Clip | HBT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Clip, Implantable | FZP | 2 | Manufacturer for export | accessdata.fda.gov |
| Closure, Wound, Adhesive | MGO | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Wire Closure, Ent, Non-Sterile | NNQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pneumoperitoneum Needle | FHO | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Trocar | DRC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Trocar, Gastro-Urology | FBQ | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 18, 2024 | K232373 | Progrip™ Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| July 17, 2020 | K200818 | 3DMax MID Anatomical Mesh | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 21, 2017 | K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 10, 2015 | K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar | GCJ | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| July 31, 2015 | K150068 | Unimicro Veress Needle | HIF | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| April 13, 2015 | K142208 | Monopolar Laparascopic Accessories | GEI | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| November 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 13, 2014 | K141593 | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH | GCJ | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| August 4, 2014 | K141592 | UNIMICRO SUCTION IRRIATION TUBING SET | GCJ | Substantially Equivalent | Unimicro Medical Systems (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| July 5, 2013 | K131511 | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR | GDW | Substantially Equivalent | Changzhou Sinolinks Medical Innovation Co., Ltd. | accessdata.fda.gov |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ligature Passing And Knot Tying
- All makers of Trocar, Gastro-Urology
- All makers of Forceps, General & Plastic Surgery
- All makers of Holder, Needle, Gastroenterologic
- All makers of Accessory, Surgical Apparel
- All makers of Mesh, Surgical, Polymeric
Updated January 18, 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.