Is this your brand? Sign in to claim ownership.

MicroAire Surgical Instruments LLC

United States·US-MF-000004063

Last updated September 17, 2026

Information

Country: United States
Address: 3590 Grand Forks Boulevard, Charlottesville, United States
Website: microaire.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Chad Wade
EUDAMED SRN: US-MF-000004063
FDA FEI Number: 2020601
DUNS Number: —

Catalogue (1286)

Page 26 of 26

Device	Model / Reference	Registries	Class	Status
Bone Harvester System & Osteotome System 2500	K900210	FDA 510(k)	Class I	Active
Osteotome Model Numbers 2500-228 & 2500-229	K903713	FDA 510(k)	Class I	Active
Micro-Aire Cast Cutter Blades	K862922	FDA 510(k)	N/A	Active
Micro-Aire Oto/Neuro Drill System	K854331	FDA 510(k)	Class II	Active
Micro-Aire Powered Micro-Surgery Instruments	K900033	FDA 510(k)	Class I	Active
Micro-Aire Oscillating Saw, 1740-000 & Wire Driver	K851443	FDA 510(k)	Class I	Active
Micro-Aire Cement Removal Tools	K880324	FDA 510(k)	Class I	Active
SMARTRELEASE Endoscopic Soft Tissue Release System	K211297	FDA 510(k)	Class II	Active
SMARTRELEASE Endoscopic Soft Tissue Release System	K181819	FDA 510(k)	Class II	Active
1.1 Couplers And 1.2 Adapters	K872550	FDA 510(k)	Class I	Active
Micro-Aire Replace Otology Burs/Zim Hall Sur Instr	K862852	FDA 510(k)	Class I	Active
Arthroscopic Surgery Blades Dy-3440, 3443, 3444	K901735	FDA 510(k)	Class II	Active
Micro-Aire Replacement Surg. Saw Blade	K831714	FDA 510(k)	Class I	Active
Oscillating Saw Blades # So-305, Mo-305 And Zo-305	K903650	FDA 510(k)	Class I	Active
Micro-Aire Osteotome System Or Bone Harvester	K874503	FDA 510(k)	Class I	Active
PAL Aspiration System	K242804	FDA 510(k)	Class II	Active
A.o. Synthes, Tap(replacement)various Model Numbers	K904949	FDA 510(k)	Class I	Active
Dendia Werk Burs And Cutting Discs	K901967	FDA 510(k)	Class I	Active
Micro Oscillating Saw	K811834	FDA 510(k)	Class I	Active
Micro-Aire Oscillating Saw Blade 202c-25, 202c-50	K896280	FDA 510(k)	Class I	Active
Micro-Aire Replacement Saw Blades	K811506	FDA 510(k)	Class I	Active
Pulse Lavage	K831230	FDA 510(k)	N/A	Active
Microaire 1000e System	K014060	FDA 510(k)	Class II	Active
Micro-Aire High Speed Oral Surgerg Drill	K850597	FDA 510(k)	Class I	Active
PAL System	K212024	FDA 510(k)	Class II	Active
PAL 7020 Console	K244026	FDA 510(k)	Class II	Active
Electro Surgery System	K841165	FDA 510(k)	Class I	Active
PAL Sterilization Case	K243589	FDA 510(k)	Class II	Active
SmartRelease Endoscopic Soft Tissue Release System	K223406	FDA 510(k)	Class II	Active
Co-Equal to Standard Blade, Smartrelease	81061-CE	EUDAMEDFDA UDI	Class I	Active
Elevator, SmartRelease	81029-CE	EUDAMEDFDA UDI	Class I	Active
SmartRelease Handpiece	83014-CE	EUDAMEDFDA UDI	Class I	Active
SmartRelease Endoscopic Soft Tisssue Release, Standard Blade Assembly	81010-6-CE	EUDAMEDFDA UDI	Class IIa	Active
Instrument Sterlization Tray, SmartRelease	83040-CE	EUDAMEDFDA UDI	Class I	Active
Co-Equal to Onyx, Smartrelease	83061-CE	EUDAMEDFDA UDI	Class I	Active
SmartRelease Endoscopic Soft Tisssue Release, Onyx Blade Assembly	83030-6-CE	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

MediMark Europe Sarl. FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (16)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 7, 2025	Z-1975-2025	—	open, classified	Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Jun 26, 2019	Z-2222-2019	—	terminated	There was a higher than normal incidence rate of the blade not retracting when tightening.
Apr 19, 2018	Z-2107-2018	—	terminated	The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
May 22, 2017	Z-0412-2018	—	terminated	One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
Feb 21, 2017	Z-1407-2017	—	terminated	Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
May 6, 2016	Z-2294-2016	—	terminated	MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Mar 11, 2016	Z-1834-2016	—	terminated	MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Feb 8, 2016	Z-1328-2016	—	terminated	MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Feb 8, 2016	Z-1323-2016	—	terminated	Complaints that the cannula bent/broke during surgery.
Jun 12, 2015	Z-2821-2015	—	terminated	There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Jun 12, 2015	Z-2822-2015	—	terminated	There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
Aug 12, 2013	Z-2159-2013	—	terminated	A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Aug 12, 2013	Z-2158-2013	—	terminated	A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
Apr 26, 2012	Z-1792-2012	—	terminated	Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures.
Sep 23, 2003	Z-0043-04	—	terminated	Wiring pin locking mechanism defective, potential to come apart in surgical site.
Sep 23, 2003	Z-0044-04	—	terminated	Wiring pin locking mechanism defective, potential to come apart in surgical site.