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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 3 of 21

Device	Model / Reference	Registries	Class	Status
Grace Piston	453-475	FDA UDI	Class II	Active
Collar Button Vent Tube	510-136C	FDA UDI	Class II	Active
Grace Bucket Handle Offset	430-450	FDA UDI	Class II	Active
DragonFly™ BUR, CTR, RD, 80MM L, 1.0MM Ø, BurShield	952-80-010-SL	FDA UDI	Class I	Active
Ha Wildcat Fixed Length Total	708-300	FDA UDI	Class II	Active
Ha Partial Prosthesis	151	FDA UDI	Class II	Active
DragonFly™ Skinny BUR, 100MM x 1.0MM	951-100-010-SB	FDA UDI	Class I	Active
Precise Centered Total	705-675	FDA UDI	Class II	Active
Reuter Bobbin Vent Tube	525-162	FDA UDI	Class II	Active
Ha Total Prosthesis	102	FDA UDI	Class II	Active
Collar Button Vent Tube	510-131C	FDA UDI	Class II	Active
Simon/Hannah Bobbin Vent Tube	500-081	FDA UDI	Class II	Active
Cueva Dissector	6.80.11	EUDAMEDFDA UDI	Class I	Active
Super E Piston	466-400	FDA UDI	Class II	Active
DragonFly™ Skinny BUR, 100MM x 0.8MM	951-100-008-SB	FDA UDI	Class I	Active
Ha Lite Alto	630-M1	FDA UDI	Class II	Unknown
Grace Medical Fluoroplastic Piston	406-600	FDA UDI	Class II	Active
Gluth Alto Total	648	FDA UDI	Class II	Unknown
Precise Offset Total	700-500	FDA UDI	Class II	Active
Bartels Bucket Handle	426-375	FDA UDI	Class II	Active
Meiti Piston	418-475	FDA UDI	Class II	Active
Malleus Measuring Rod	901	EUDAMEDFDA UDI	Class I	Active
Total Tilt Top Head Notched	204	FDA UDI	Class II	Active
Shepard Grommet	510-021C	FDA UDI	Class II	Active
Bojrab Alto Total	625	FDA UDI	Class II	Unknown
Precise Offset Total	700-350	FDA UDI	Class II	Active
Ha Wildcat Fixed Length Total	708-400	FDA UDI	Class II	Active
Grace Medical Fluoroplastic Piston	402-400	FDA UDI	Class II	Active
Armstrong R Vent Tube	510-283	FDA UDI	Class II	Active
Rivas Suction Dissector, Angled 90°	999-105	FDA UDI	Class I	Active
Alto Cutter W/O Ring	912	EUDAMEDFDA UDI	Class I	Active
Grace Piston	453-400	FDA UDI	Class II	Active
Pediatric Bobbin Vent Tube	500-061	FDA UDI	Class II	Active
Wildcat Pro, 3.00mm L	709-300	FDA UDI	Class II	Active
Touma Vent Tube W/Tab	510-521C	FDA UDI	Class II	Active
Paparella Vent Tube W/Tab	520-131	FDA UDI	Class II	Active
Beveled Bobbin Vent Tube	525-171	FDA UDI	Class II	Active
Ha Lite Alto Partial	685	FDA UDI	Class II	Unknown
Grace Medical Fluoroplastic Piston	402-450	FDA UDI	Class II	Active
Kraus K-Helix Piston	757-300	FDA UDI	Class II	Active
Armstrong Vent Tube	525-502	FDA UDI	Class II	Active
Frisbee Partial	750-050	FDA UDI	Class II	Active
Bojrab Dissector, Small, Angled 20°	999-DB3	EUDAMEDFDA UDI	Class I	Active
Friedman Style Collar Button	525-233	FDA UDI	Class II	Active
Paparella Vent Tube	510-323	FDA UDI	Class II	Active
Grace Bucket Handle Offset	430-600	FDA UDI	Class II	Active
Mazzawi Piston	462-450	FDA UDI	Class II	Active
Pope Vent Tube	510-161C	FDA UDI	Class II	Active
Wedge Incus Strut Short	657	FDA UDI	Class II	Active
DragonFly™ BUR, CTR, CYL, 80MM L, 1.8MM Ø, BurShield	954-80-018-SL	FDA 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.