Allwin Medical Devices, Inc.
Anaheim, CA, US
ALLWIN MEDICAL DEVICES, INC. appears in FDA device records in Anaheim, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Allwin Medical Devices, Inc. between 2019 and 2023. The busiest year on record is 2019, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | EZN | Substantially Equivalent | |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | KOD | Substantially Equivalent | |
| K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | MQK | Substantially Equivalent | |
| K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | MQF | Substantially Equivalent | |
| K190659 | Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip | FAD | Unknown | |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | MQE | Substantially Equivalent | |
| K190522 | Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) | MQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005987240 | 3005987240 | ALLWIN MEDICAL DEVICES, INC. | 3305 E. MIRALOMA AVENUE, ANAHEIM, CA 92806 US | 2026 | and 50 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- FEBAccessories, Cleaning, For Endoscope
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- HFFAspirator, Endometrial
- EOQBronchoscope (Flexible Or Rigid)
- MFDCannula, Intrauterine Insemination
- LKFCannula, Manipulator/Injector, Uterine
- MQFCatheter, Assisted Reproduction
- LFKCatheter, Femoral
- MSDCatheter, Hemodialysis, Implanted
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- LJECatheter, Nephrostomy
- GBOCatheter, Nephrostomy, General & Plastic Surgery
- FKOCatheter, Peritoneal Dialysis, Single Use
- KOBCatheter, Suprapubic (And Accessories)
- GBLCatheter, Ureteral, General & Plastic Surgery
- KODCatheter, Urological
- FHAClamp, Penile
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- HHKCurette, Suction, Endometrial (And Accessories)
- GCCDilator, Catheter
- EZNDilator, Catheter, Ureteral
- HDQDilator, Cervical, Fixed Size
- KOEDilator, Urethral
- FFLDislodger, Stone, Basket, Ureteral, Metal
- LQRDislodger, Stone, Biliary
- FGODislodger, Stone, Flexible
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- MNKEndoscopic Bite Block
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FFDEvacuator, Bladder, Manually Operated
- KQTEvacuator, Gastro-Urology
- HTDForceps
- FCLForceps, Biopsy, Non-Electric
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- MQKLabware, Assisted Reproduction
- FHNLigator, Hemorrhoidal
- LQCLithotriptor, Biliary Mechanical
- FFKLithotriptor, Electro-Hydraulic
- FTLMesh, Surgical, Polymeric
- MQJMicromanipulators And Microinjectors, Assisted Reproduction
- GAANeedle, Aspiration And Injection, Disposable
- GDMNeedle, Aspiration And Injection, Reusable
- MQENeedle, Assisted Reproduction
- DWONeedle, Biopsy, Cardiovascular
- ESWProsthesis, Esophageal
- FDISnare, Flexible
- HHTSpatula, Cervical, Cytological
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- EZBStylet For Catheter, Gastro-Urology
- EYAStylet, Ureteral
- KYZSyringe, Irrigating (Non Dental)
- HDDTable, Obstetrical, Ac-Powered (And Accessories)
- FBQTrocar, Gastro-Urology
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- KNTTubes, Gastrointestinal (And Accessories)
- EXYUroflowmeter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain