Question 1

What types of medical devices does Alliance Medical, Inc. manufacture?

Accepted Answer

Alliance Medical, Inc. produces reprocessed orthopedic and surgical devices such as compression sleeves, soft‑tissue ablators, arthroscopic and diamond burs, external fixation devices, electrophysiology catheters, phacoemulsification tips, and a disposable sterile drape sheet. This list is taken directly from the provided device data, so no other products are assumed.

Question 2

Where is Alliance Medical, Inc. located and under which regulatory framework are its devices listed?

Accepted Answer

The company is based in the United States, as indicated by the COUNTRY field. Its devices appear in the FDA 510(k) database, meaning they are subject to the FDA’s 510(k) premarket submission process. This information comes from the LISTED IN entry in the data.

Question 3

How are the devices from Alliance Medical, Inc. classified under FDA regulations?

Accepted Answer

According to the DEVICE CLASSES entry, Alliance Medical’s products are classified as Class II and Class U medical devices. Class II devices are moderate‑risk devices requiring special controls, while Class U denotes unclassified devices that are reviewed on a case‑by‑case basis. This classification is explicitly stated in the data.

Question 4

Are Alliance Medical, Inc.’s devices approved or cleared by the FDA?

Accepted Answer

The data only indicates that the devices are listed in the FDA 510(k) database and assigned to Class II or Class U. It does not state that any specific device has received FDA approval, clearance, or certification, and we must not infer such status. Therefore, we can only confirm their regulatory listing, not an approval.

Device	Model / Reference	Registries	Class	Status
Reprocessed Compression Sleeve	K021654	FDA 510(k)	Class II	Active
Reprocessed Ep Technologies Electrophysiology Catheters	K043393	FDA 510(k)	Class II	Active
Vanguard Reprocessed Compression Garments (hill-Rom)	K051438	FDA 510(k)	Class II	Active
All Flow Pulmonary Function Filter	K043148	FDA 510(k)	Class II	Active
Reprocessed Unipolar Laparoscopic/Endoscopic Instruments	K012625	FDA 510(k)	Class II	Active
Reprocessed Stryker Arthroscopic Shavers	K012635	FDA 510(k)	Class II	Active
Reprocessed Howmedica External Fixation Devices	K012648	FDA 510(k)	Class II	Active
Reprocessed Compression Sleeves	K053316	FDA 510(k)	Class II	Active
Reprocessed Ebi External Fixation Devices	K012645	FDA 510(k)	Class II	Active
Reprocessed Daig Livewire Electrophysiology Catheters	K052603	FDA 510(k)	Class II	Active
Echo. Akho	K951976	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Catheter	K030026	FDA 510(k)	Class II	Active
Modification To Reprocessed Synthes External Fixation Devices	K032058	FDA 510(k)	Class II	Active
Reprocssed Linvatec Shavers	K012613	FDA 510(k)	Class II	Active
Reprocessed Endoscopic Trocars And Cannulas	K024015	FDA 510(k)	Class II	Active
Reprocessed Dyonics Arthroscopic Burs	K012652	FDA 510(k)	Class II	Active
Alliance Medical Corporation Reprocessed External Fixation Devices	K052062	FDA 510(k)	Class II	Active
Compressible Limb Sleeve	K011192	FDA 510(k)	Class II	Active
Reprocessed Compression Sleeves	K060049	FDA 510(k)	Class II	Active
Reprocessed Autosuture Unipolar Laparoscopic/Endoscopic Instruments	K012603	FDA 510(k)	Class II	Active
Reprocessed Electrophysiology Catheters	K043392	FDA 510(k)	Class II	Active
Electrophysiology Catheter	K030109	FDA 510(k)	Class II	Active
Reprocessed Dyonics Arthroscopic Shavers	K012611	FDA 510(k)	Class II	Active

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