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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 6 of 21

Device	Model / Reference	Registries	Class	Status
Shepard Grommet Vent Tube	520-042	FDA UDI	Class II	Active
Supersoft™ T-Tube	510-361	FDA UDI	Class II	Active
Grace Piston	453-425	FDA UDI	Class II	Active
2 In 1 Alto	642	FDA UDI	Class II	Active
Nano Alto Byte	654	FDA UDI	Class II	Active
Grace Piston	412-375	FDA UDI	Class II	Active
Titanium Piston	413-450	FDA UDI	Class II	Active
Lippy Bucket	431-450	FDA UDI	Class II	Active
Frisbee Partial	750-150	FDA UDI	Class II	Active
Memphis Bobbin Vent Tube	500-022M	FDA UDI	Class II	Active
Armstrong X Vent Tube	525-203	FDA UDI	Class II	Active
Grace Medical Fluoroplastic Piston	408-600	FDA UDI	Class II	Active
Bobbin Vent Tube	500-011	FDA UDI	Class II	Active
Ha Total Prosthesis	106	FDA UDI	Class II	Active
Dornhoffer Alto Partial	695-M1	FDA UDI	Class II	Active
Ha Lite Alto Total W/Integrated Shoe	630B	FDA UDI	Class II	Active
Lippy Bucket	431-500	FDA UDI	Class II	Active
Grace Medical Fluoroplastic Piston	403-350	FDA UDI	Class II	Active
Paparella Vent Tube W/Tab	510-043	FDA UDI	Class II	Active
Lippy Bucket Handle W/Notch	423-475	FDA UDI	Class II	Active
Fluoroplastic Piston	400-450	FDA UDI	Class II	Active
DragonFly™, POWERED BY InvisiDrive™ HANDPIECE	950-002	FDA UDI	Class II	Active
Bojrab Dissection Needle, Angled 20°	999-DB4	EUDAMEDFDA UDI	Class I	Active
Titanium Piston	461-500	FDA UDI	Class II	Active
Grace Piston	412-500	FDA UDI	Class II	Active
Ha Total Prosthesis	103	FDA UDI	Class II	Active
Lippy Bucket Handle W/Notch	423-375	FDA UDI	Class II	Active
Paparella Vent Tube W/Tab	510-052	FDA UDI	Class II	Active
Bobbin Vent Tube	525-021	FDA UDI	Class II	Active
Offset Alto Partial	650	FDA UDI	Class II	Unknown
Total Tilt Top Head Notched	208	FDA UDI	Class II	Active
Grace Medical Titanium Round Wire Piston	463-350	FDA UDI	Class II	Active
Collar Button Vent Tube	510-133	FDA UDI	Class II	Active
Precise Centered Partial	765-125	FDA UDI	Class II	Active
Eclipse Piston	468-525	FDA UDI	Class II	Active
Titanium Piston	460-425	FDA UDI	Class II	Active
Precise Offset Partial	751-075	FDA UDI	Class II	Active
Ha Frisbee Partial	749-200	FDA UDI	Class II	Active
Tapervent Tube	510-141	FDA UDI	Class II	Active
Gluth Alto Partial	678	FDA UDI	Class II	Unknown
Bojrab Alto Total W/Integrated Shoe	625B	FDA UDI	Class II	Active
Bobbin Vent Tube	520-022	FDA UDI	Class II	Active
Precise Offset Total	700-525	FDA UDI	Class II	Active
Olson Micro Dissector	999-203	EUDAMEDFDA UDI	Class I	Active
EndoEar™ SUCTION	1.80.05	EUDAMEDFDA UDI	Class I	Active
Super E Piston	465-425	FDA UDI	Class II	Active
DragonFly™ BUR, DMD, RD, 95MM L, 0.6MM Ø	951-95-006	FDA UDI	Class I	Active
Centered Alto Total	605-M1	FDA UDI	Class II	Active
Robinson Bucket Handle	420-375	FDA UDI	Class II	Active
Cueva Dissector, Straight	991-RC1	EUDAMEDFDA UDI	Class I	Active

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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.