FlareHawk

General Instrument/ Graft Delivery Tray, FH7

Registry build 21.09.26
105manufacturers in China registered for this device type
62catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for FlareHawk
Listed by Highridge Medical, LLC, United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2025-10-03
Record revised 2026-03-20 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for FlareHawk
Catalogue number Size Status
ASY-01030 In distribution
ASY-01031 In distribution
ASY-00579 In distribution
ASY-00523 In distribution
II-1-0354 In distribution
ASY-00526 In distribution
ASY-00823 In distribution
ASY-01173 In distribution
ASY-00486 In distribution
CMP-00708 In distribution
ASY-01175 In distribution
ASY-01164 In distribution
ASY-00433 In distribution
ASY-00996 In distribution
ASY-00522 In distribution
ASY-00414 In distribution
ASY-00527 In distribution
ASY-00581 In distribution
ASY-00436 In distribution
ASY-00489 In distribution
ASY-01017 In distribution
ASY-01176 In distribution
ASY-00144 In distribution
ASY-00986 In distribution
II-1-0144 In distribution
ASY-00410 In distribution
ASY-00420 In distribution
ASY-00857 In distribution
ASY-00421 In distribution
ASY-01188 In distribution
ASY-00370 In distribution
ASY-00484 In distribution
ASY-00499 In distribution
ASY-00580 In distribution
ASY-00367 In distribution
II-1-0267 In distribution
ASY-01029 In distribution
ASY-00369 In distribution
CMP-00587 In distribution
ASY-00437 In distribution
ASY-00485 In distribution
ASY-00997 In distribution
ASY-01189 In distribution
ASY-01016 In distribution
ASY-00521 In distribution
ASY-00415 In distribution
ASY-00653 In distribution
ASY-01172 In distribution
ASY-01028 In distribution
ASY-00438 In distribution
ASY-00525 In distribution
II-1-0146 In distribution
ASY-01165 In distribution
ASY-01168 In distribution
ASY-01174 In distribution
ASY-00524 In distribution
ASY-00419 In distribution
ASY-00582 In distribution
ASY-00368 In distribution
ASY-00480 In distribution
II-1-0268 In distribution
II-1-0145 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Acumed Acumed LLC 566
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer