Skip to the page
Get started – free

Data / Medical devices / United States / Allwin Medical Devices, Inc.

Allwin Medical Devices, Inc.: FDA-registered device maker in Anaheim, CA, United States, 8 510(k) clearances

Allwin Medical Devices, Inc. is registered with the FDA (registration 3005987240) in Anaheim, CA, United States. It lists 60 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 9, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Allwin Medical Devices, Inc.
FDA registration number
3005987240
Address
3305 E. Miraloma Avenue Suite 176, Anaheim, CA, United States, 92806
Owner or operator
ALLWIN MEDICAL DEVICES, INC. (9094082)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed
October 30, 2006
Registered through
2026
Brand names listed
ACE Single Lumen Ovum Pickup Needle 16G, 17G, 18G, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line 16G, 17G, 18G, ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 17G, 18G, ARMADA Amplatz Renal Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Renal Dilator, ARMADA Ureteral Dilator Set, ASPI Aspiration Needle 18G, 22G and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Blood Circuit, HemodialysisKOC2Manufacturer for exportaccessdata.fda.gov
Accessories, Cleaning, For EndoscopeFEB2Manufacturer for exportaccessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For EndoscopeFFY1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Manufactureraccessdata.fda.gov
Aspirator, EndometrialHFF2Manufacturer for exportaccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Manufacturer for exportaccessdata.fda.gov
Cannula, Intrauterine InseminationMFD2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Cannula, Manipulator/Injector, UterineLKF2Manufacturer for exportaccessdata.fda.gov
Catheter, Assisted ReproductionMQF2Manufactureraccessdata.fda.gov
Catheter, FemoralLFK2Manufacturer for exportaccessdata.fda.gov
Catheter, Hemodialysis, ImplantedMSD2Manufacturer for exportaccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Manufacturer for exportaccessdata.fda.gov
Catheter, NephrostomyLJEUManufactureraccessdata.fda.gov
Catheter, Nephrostomy, General & Plastic SurgeryGBO1Manufactureraccessdata.fda.gov
Catheter, Peritoneal Dialysis, Single UseFKO2Manufacturer for exportaccessdata.fda.gov
Catheter, Suprapubic (And Accessories)KOB2Manufacturer for exportaccessdata.fda.gov
Catheter, Ureteral, General & Plastic SurgeryGBLNManufacturer for exportaccessdata.fda.gov
Catheter, UrologicalKOD2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Clamp, PenileFHA1Repackager or relabeleraccessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling CatheterKNX2Repackager or relabeleraccessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)HHK2Manufacturer for exportaccessdata.fda.gov
Dilator, CatheterGCC1Repackager or relabeleraccessdata.fda.gov
Dilator, Catheter, UreteralEZN2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Manufacturer for exportaccessdata.fda.gov
Dilator, UrethralKOE2Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, MetalFFL2Repackager or relabeleraccessdata.fda.gov
Dislodger, Stone, BiliaryLQR2Manufacturer for exportaccessdata.fda.gov
Dislodger, Stone, FlexibleFGO2Manufacturer for exportaccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Manufacturer for exportaccessdata.fda.gov
Endoscopic Bite BlockMNK1Repackager or relabeleraccessdata.fda.gov
Endoscopic Cytology BrushFDX2Manufacturer for exportaccessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-UrologyFBK2Manufacturer for exportaccessdata.fda.gov
Evacuator, Bladder, Manually OperatedFFD1Manufactureraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufacturer for exportaccessdata.fda.gov
Instrument, Manual, Specialized Obstetric-GynecologicKNA2Manufacturer for exportaccessdata.fda.gov
Labware, Assisted ReproductionMQK2Manufactureraccessdata.fda.gov
Ligator, HemorrhoidalFHN2Repackager or relabeleraccessdata.fda.gov
Lithotriptor, Biliary MechanicalLQC2Repackager or relabeleraccessdata.fda.gov
Lithotriptor, Electro-HydraulicFFK2Manufacturer for exportaccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Manufacturer for exportaccessdata.fda.gov
Micromanipulators And Microinjectors, Assisted ReproductionMQJ2Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Manufacturer for exportaccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeleraccessdata.fda.gov
Needle, Assisted ReproductionMQE2Manufactureraccessdata.fda.gov
Needle, Biopsy, CardiovascularDWO1Repackager or relabeleraccessdata.fda.gov
Prosthesis, EsophagealESW2Manufacturer for exportaccessdata.fda.gov
Snare, FlexibleFDI2Manufacturer for exportaccessdata.fda.gov
Spatula, Cervical, CytologicalHHT2Manufacturer for exportaccessdata.fda.gov
Stent, UreteralFAD2Manufactureraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Manufacturer for exportaccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Repackager or relabeleraccessdata.fda.gov
Stylet, UreteralEYA1Repackager or relabeleraccessdata.fda.gov
Syringe, Irrigating (Non Dental)KYZ1Manufacturer for export, Repackager or relabeleraccessdata.fda.gov
Table, Obstetrical, Ac-Powered (And Accessories)HDD2Manufactureraccessdata.fda.gov
Trocar, Gastro-UrologyFBQ2Repackager or relabeleraccessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or IntubationFEG2Manufacturer for exportaccessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)KNT2Manufacturer for exportaccessdata.fda.gov
UroflowmeterEXY2Repackager 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
October 9, 2026K261234The D-Tip Denudation PipetteMQHSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
May 5, 2023K220781ARMADA 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 CatheterEZNSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
October 13, 2022K220730allFlex Ureteral Catheters, Krait Ureteral CathetersKODSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
June 4, 2021K203626SureStrip Vitrification Straw, SureLock Vitrification StrawMQKSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
July 1, 2020K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQFSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
December 2, 2019K190659Ureteral 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 TipFADUnknownAllwin Medical Devices, Inc.accessdata.fda.gov
November 25, 2019K190590Allwin 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)MQESubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov
November 14, 2019K190522Allwin 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)MQFSubstantially EquivalentAllwin Medical Devices, Inc.accessdata.fda.gov

Compare with other makers

Updated October 9, 2026. 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.