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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 4 of 21

Device	Model / Reference	Registries	Class	Status
Offset Alto Partial	650-M1	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.84.03	EUDAMEDFDA UDI	Class I	Active
Lippy Bucket	425-350	FDA UDI	Class II	Active
Robinson Bucket	432-400	FDA UDI	Class II	Active
Offset Nano Alto Total	603	FDA UDI	Class II	Unknown
DragonFly™ BUR, CTR, RD, 80MM L, 1.8MM Ø, BurShield	952-80-018-SL	FDA UDI	Class I	Active
Bojrab Dissector, Large, Angled 90°	999-DB5	FDA UDI	Class I	Active
Bojrab Dissector, Small, Angled 20°	999-DB3	FDA UDI	Class I	Active
Precise Byte	752-200	FDA UDI	Class II	Active
Precise Centered Total	705-625	FDA UDI	Class II	Active
Robinson Bucket Handle	422-475	FDA UDI	Class II	Active
Lippy Bucket	421-550	FDA UDI	Class II	Active
DragonFly™ BUR, CTR, RD, 80MM L, 0.8MM Ø, BurShield	952-80-008-SL	FDA UDI	Class I	Active
Grace Medical Titanium Round Wire Piston	463-425	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	525-123	FDA UDI	Class II	Active
Grace Medical Straight Vent Tube	520-091	FDA UDI	Class II	Active
EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.	EE-0300	FDA UDI	Class II	Active
Offset Alto Total	600-M1	FDA UDI	Class II	Active
Bartels Bucket Handle	427-475	FDA UDI	Class II	Active
Ha Total Prosthesis	108	FDA UDI	Class II	Active
Eclipse De La Cruz Piston	469-475	FDA UDI	Class II	Active
Eclipse Piston	464-800	FDA UDI	Class II	Active
Precise Offset Partial	750-425	FDA UDI	Class II	Active
Wildcat Pro, 5.50mm L	709-550	FDA UDI	Class II	Active
Shepard Grommet Vent Tube	525-121	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.82.05	EUDAMEDFDA UDI	Class I	Active
Armstrong Vent Tube	520-502	FDA UDI	Class II	Active
Grace Medical T-Tube	510-101	FDA UDI	Class II	Active
Grace Medical T-Tube	510-111	FDA UDI	Class II	Active
Ha Total Prosthesis	111	FDA UDI	Class II	Active
Robinson Bucket Handle	422-500	FDA UDI	Class II	Active
Precise Ha Lite Total	720-350	FDA UDI	Class II	Active
Linstrom Piston	419-400	FDA UDI	Class II	Active
Bojrab Dissection Round Knife, 2.5mm Dia	999-DB8	FDA UDI	Class I	Active
Reuter Bobbin Vent Tube	520-682	FDA UDI	Class II	Active
Baxter Beveled Bobbin Vent Tube	520-212	FDA UDI	Class II	Active
Precise Offset Total	700-575	FDA UDI	Class II	Active
Triune Trumpet Vent Tube	510-301	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.80.03	EUDAMEDFDA UDI	Class I	Active
Titanium Piston	413-400	FDA UDI	Class II	Active
Total Tilt Top Head Centered	201	FDA UDI	Class II	Active
Grace Medical Titanium Round Wire Piston	463-400	FDA UDI	Class II	Active
Spoon Bobbin Vent Tube	500-041	FDA UDI	Class II	Active
Modified Armstrong Grommet	525-183	FDA UDI	Class II	Active
Triune Trumpet Vent Tube	510-302	FDA UDI	Class II	Active
Grace Bucket Handle Offset	430-425	FDA UDI	Class II	Active
Precise Owens Assure Partial	652-275	FDA UDI	Class II	Active
EndoEar™ SUCTION	1.83.03	EUDAMEDFDA UDI	Class I	Active
Precise Centered Nytebyte Partial	753-125	FDA UDI	Class II	Active
Bobbin Vent Tube	500-021	FDA UDI	Class II	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.