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Grace Medical, Inc.

United States·US-MF-000026047

Last updated September 17, 2026

Information

Country: United States
Address: 8500 Wolf Lake Drive, Memphis, United States
Website: gracemedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(866)472-2363
PRRC Contact: Thomas Fearnley
EUDAMED SRN: US-MF-000026047
FDA FEI Number: 1000022662
DUNS Number: 030849173

Catalogue (1029)

Page 1 of 21

Device	Model / Reference	Registries	Class	Status
Hough Flap Knife, Double Ended Angled 25°/45° Ss W/ Diamond-Coating	999-204	EUDAMED	Class I	Active
Thomassin Dissector, Double Ended Angled Left And Right Ss W/ Diamond-Coating	999-205	EUDAMED	Class I	Active
Centered Alto Partial	655	FDA UDI	Class II	Active
Grace Piston	452-375	FDA UDI	Class II	Active
Triune Vent Tube	510-123	FDA UDI	Class II	Active
Lee No.3 Suction Dissector	6.80.03	EUDAMEDFDA UDI	Class I	Active
Paparella Vent Tube	510-061C	FDA UDI	Class II	Active
Ha Total Prosthesis	109	FDA UDI	Class II	Active
EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.	EE-0370	FDA UDI	Class II	Active
Bojrab Total	625-M1	FDA UDI	Class II	Active
Grace Piston	453-450	FDA UDI	Class II	Active
Dornhoffer Alto Total W/Shoe & Windows	626	FDA UDI	Class II	Unknown
Donaldson Vent Tube	510-016	FDA UDI	Class II	Active
Bojrab Alto Precut	640	FDA UDI	Class II	Active
Accutip And Drape	926-002	FDA UDI	Class I	Active
Precise Centered Partial	765-400	FDA UDI	Class II	Active
Wildcat Pro, 4.50mm L	709-450	FDA UDI	Class II	Active
Collar Button Vent Tube	510-241	FDA UDI	Class II	Active
Reuter Bobbin Vent Tube	500-101	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	525-123W	FDA UDI	Class II	Active
Bojrab Dissector, Large, Angled 115°	999-DB5	EUDAMEDFDA UDI	Class I	Active
Grace Medical Fluoroplastic Piston	403-600	FDA UDI	Class II	Active
Precise Centered Partial	765-375	FDA UDI	Class II	Active
Triune Vent Tube	510-121C	FDA UDI	Class II	Active
Bojrab Dissector, Large, Angled 20°	999-DB1	FDA UDI	Class I	Active
Eclipse Piston	467-425	FDA UDI	Class II	Active
Precise Centered Total 2.00mm L	705-200	FDA UDI	Class II	Active
Sliding Measuring Rod	905	EUDAMEDFDA UDI	Class I	Active
Alto Cutter	910	EUDAMEDFDA UDI	Class I	Active
Dornhoffer Alto Total W/Windows	637	FDA UDI	Class II	Active
DragonFly™ Skinny BUR, 100MM x 1.4MM	951-100-014-SB	FDA UDI	Class I	Active
Lee No.1 Suction Dissector	6.80.01	EUDAMEDFDA UDI	Class I	Active
Collar Button Vent Tube	510-243C	FDA UDI	Class II	Active
Armstrong R Vent Tube	510-311	FDA UDI	Class II	Unknown
Cueva Dissector, Right	991-RC2	EUDAMEDFDA UDI	Class I	Active
Moretz Vent Tube W/Tab	500-132	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.81.20	EUDAMEDFDA UDI	Class I	Active
Eclipse Piston	467-600	FDA UDI	Class II	Active
Bartels Bucket Handle	427-425	FDA UDI	Class II	Active
Precise Offset Total	700-400	FDA UDI	Class II	Active
Linstrom Piston	419-450	FDA UDI	Class II	Active
Paparella Vent Tube W/Tab	510-061	FDA UDI	Class II	Active
Pope Vent Tube	510-162	FDA UDI	Class II	Active
Shepard Grommet Vent Tube W/Tab	525-046	FDA UDI	Class II	Active
Ha Partial Strut	190-490	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	525-043	FDA UDI	Class II	Active
Eclipse Piston	468-600	FDA UDI	Class II	Active
Moretz Ha Delta Mini Head Alto Partial	697	FDA UDI	Class II	Active
Ha Alto Total	620	FDA UDI	Class II	Active
Centered Duo Alto Total W/Stapes Adapter	605A	FDA UDI	Class II	Unknown

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FDA Recalls (1)

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
Apr 3, 2026	Z-2308-2026	—	open, classified	Due to incorrect functional length on device labeling.