FDA Registration Active 🇺🇸 United States

GRACE MEDICAL, INC.

Reg #: 1057421 · FEI: 1000022662 · Expires 2026
Products
23
Proprietary Names
326
Establishment Types
4
Classifications
23

Registration Details

Registration Name
GRACE MEDICAL, INC.
Registration Number
1057421
FEI Number
1000022662
Status
Active
Expiry Year
2026
Initial Importer
No
Address
8500 WOLF LAKE DR. SUITE 110
City
Memphis
State
TN
ZIP
38133
Country
US

Regulatory Submissions

510(k) Number
K963752

Owner / Operator

Firm Name
GRACE MEDICAL GROUP, INC.
Operator Number
9067138
Address
8500 WOLF LAKE DR., SUITE 110
City
Memphis
State
TN
Postal Code
38133
Country
US

Products

Device Name Product Code
Catheter, Irrigation GBX
Instrument, Ent Manual Surgical LRC
Prosthesis, Partial Ossicular Replacement ETB
Replacement, Ossicular Prosthesis, Total ETA
Tube, Tympanostomy ETD
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
Knife, Ear JYO
Tray, Surgical, Ent MMO
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Gauge, Measuring JYJ
Tube, Ear Suction JZF
Trap, Sterile Specimen BYZ
Cutter, Surgical FZT
Applicator, Ent KCJ
Retractor, Ent KAL
Dressing, Compression MHW
Bone Particle Collector MXP
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Bur, Ear, Nose And Throat EQJ
Nasopharyngoscope (Flexible Or Rigid) EOB
Forceps, Ent KAE
Drape, Surgical, Exempt PUI
Blower, Powder, Ent KCL

Proprietary Names

OtoMed BOJRAB DISSECTION NEEDLE, ANGLED 20° SUCTION DISSECTOR, ANGLED 110° LEE NO.1 SUCTION DISSECTOR RIVAS SUCTION DISSECTOR, ANGLED 90° LEE No.7 DISSECTOR, DOUBLE-ENDED BOJRAB DISSECTOR, LARGE, ANGLED 115° LEE No.8 DISSECTOR, DOUBLE-ENDED SUCTION DISSECTOR, ANGLED 45° LEE NO.3 SUCTION DISSECTOR CUEVA DISSECTOR CUEVA DISSECTOR, STRAIGHT SUCTION ADAPTER, ROTATABLE 360° OLSON MICRO HOOK ALTO CUTTER W/O RING BOJRAB DISSECTOR, LARGE, ANGLED 90° FEATHERVAC FLAT RIBBON STAPES SEAT LEE No.10 DISSECTOR, DOUBLE-ENDED RIVAS SUCTION DISSECTOR, ANGLED 110° FEATHERVAC DISPOSABLE STAPES SEAT BOJRAB DISSECTOR, SMALL, ANGLED 90° CUEVA DISSECTOR, LEFT BOJRAB DISSECTOR, MEDIUM, ANGLED 25° CUEVA DISSECTOR, RIGHT BOJRAB DISSECTOR, LARGE, ANGLED 24° OLSON MICRO DISSECTOR BOJRAB DISSECTOR, MEDIUM, ANGLED 90° OLSON MICRO NEEDLE ALTO CUTTER RIVAS SUCTION ELEVATOR BOJRAB DISSECTOR, SMALL, ANGLED 20° LEE No.9 DISSECTOR, DOUBLE-ENDED SUCTION DISSECTOR, ANGLED 90° LEE NO.2 SUCTION DISSECTOR RIVAS SUCTION DISSECTOR, ANGLED 45° BOJRAB DISSECTOR, MEDIUM, ANGLED 115° SUCTION ROUND KNIFE, 1MM DIAMETER BOJRAB DISSECTOR, SMALL, ANGLED 115° PROCEM PREPARATION STATION MICRO DISSECTOR FOR SINUS TYMPANI SUCTION ROUND KNIFE, 1.5MM DIAMETER ApollOS Endo Ear ACCUTIP AND DRAPE MICRO DISSECTOR FOR EAR DRUM BOJRAB DISSECTOR, MEDIUM, ANGLED 20° BOJRAB DISSECTOR, LARGE, ANGLED 20° HA PARTIAL PROSTHESIS HA PARTIAL STRUT Grace Medical HA TOTAL PROSTHESIS HA TOTAL STRUT HA FOOTPLATE SHOE BOBBIN VENT TUBE BEVELED BOBBIN VENT TUBE REUTER BOBBIN VENT TUBE ARMSTRONG X VENT TUBE SHEPARD GROMMET VENT TUBE BAXTER BEVELED BOBBIN SHEEHY COLLAR BUTTON VENT TUBE DONALDSON VENT TUBE SHEPARD GROMMET VENT TUBE W/TAB MODIFIED ARMSTRONG GROMMET ARMSTRONG R VENT TUBE FRIEDMAN STYLE COLLAR BUTTON DragonFly BATTERY SET DragonFly, POWERED BY InvisiDrive HANDPIECE DragonFly SURGICAL DRILL SYSTEM POWERED BY Invisidrive DragonFly ANGLED ADAPTOR-35° DragonFly DragonFly FOOTSWITCH DragonFly STERILIZATION TRAY DragonFly ANGLED ADAPTOR-15° DragonFly ANGLED ADAPTOR-25° DragonFly CHARGING SYSTEM BOJRAB DISSECTION ROUND KNIFE, 2.54MM DIA BOJRAB DISSECTION ROUND KNIFE, 2.5MM DIA BOJRAB DISSECTION SICKLE KNIFE CARTILAGE MICROTOME STERILIZATION TRAY HABERMAN ALTO PARTIAL RECTANGLE HEAD CENTERED DUO ALTO TOTAL W/STAPES ADAPTER HABERMAN ALTO PARTIAL ROUND HEAD OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE CENTERED ALTO NYTEBYTE PARTIAL CENTERED ALTO SATALOFF ALTO PARTIAL BOJRAB ALTO TOTAL HA ALTO PARTIAL MORETZ ALTO HA, RIGHT GLUTH ALTO TOTAL HABERMAN ALTO TOTAL ROUND HEAD MALLEUS MEASURING ROD MORETZ ALTO HA, LEFT DORNHOFFER ALTO TOTAL DORNHOFFER ALTO PARTIAL W/WINDOWS ALTO TOTAL OWENS ASSURE ALTO PARTIAL BOJRAB ALTO PARTIAL OFFSET NANO ALTO TOTAL HA LITE ALTO PARTIAL OFFSET DUO ALTO TOTAL W/STAPES ADAPTER CENTERED ALTO PARTIAL NANO ALTO BYTE HA LITE ALTO TOTAL W/INTEGRATED SHOE MORETZ HA DELTA MINI HEAD ALTO TOTAL CENTERED ALTO TOTAL W/INTEGRATED SHOE MOLDED OTOLOGIC SIZERS 2 IN 1 ALTO OFFSET ALTO TOTAL GLUTH ALTO PARTIAL OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE MORETZ HA DELTA MINI HEAD ALTO PARTIAL CENTERED ALTO PARTIAL 10MM L DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS MALLEABLE TITANIUM MEASURING ROD DORNHOFFER ALTO PARTIAL OFFSET ALTO CONCISE PARTIAL CENTERED ALTO TOTAL CENTERED NANO ALTO PARTIAL BENSON UNIVERSAL IMPLANT SIZER SLIDING MEASURING ROD BOJRAB TOTAL WEDGE INCUS STRUT SHORT CENTERED NANO ALTO TOTAL HA LITE ALTO SATALOFF ALTO TOTAL CENTERED ALTO CONCISE PARTIAL GANTZ ALTO TOTAL BOJRAB ALTO TOTAL W/INTEGRATED SHOE DORNHOFFER ALTO NYTEBYTE PARTIAL DORNHOFFER ALTO TOTAL W/WINDOWS HA LITE ALTO NYTEBYTE PARTIAL HA LITE ALTO TOTAL HA ALTO TOTAL WEDGE INCUS STRUT LONG SILVERSTEIN ALTO TOTAL W/TACK OWENS ASSURE ALTO TOTAL WILDCAT PRO ALTO TOTAL OFFSET ALTO PARTIAL CENTERED ALTO BYTE PARTIAL BOJRAB ALTO PRECUT OFFSET NANO ALTO PARTIAL FEATHERVAC REUSABLE SUCTION ROLAND DIRECTIONAL S/I, 5FR. x 8CM ROLAND DIRECTIONAL S/I, 7FR. x 10CM ROLAND DIRECTIONAL S/I, 10FR. x 8CM Vent Tube ROLAND DIRECTIONAL S/I, 5FR. x 10CM ROLAND DIRECTIONAL S/I, 7FR. x 8CM EndoEar SUCTION ROLAND DIRECTIONAL S/I, 12FR. x 8CM MINI-REVERSIBLE VENT TUBE RUBE VENT TUBE W/TAB GRACE MEDICAL T-TUBE COLLAR BUTTON VENT TUBE MODIFIED COLLAR BUTTON VENT TUBE TRIUNE VENT TUBE TRIUNE TRUMPET VENT TUBE TINY TRIUNE VENT TUBE BOJRAB TINY TRIUNE PAPARELLA VENT TUBE TOUMA VENT TUBE W/ TAB SHEA PARASOL VENT TUBE W/TAB CANOE VENT TUBE TAPERVENT TUBE PAPARELLA VENT TUBE W/TAB POPE VENT TUBE CARTILAGE MICROTOME HANDLE Cartilage MACROTOME Tissue Support TISSUE SUPPORT DIAL Cartilage MACROTOME Handle Cartilage MACROTOME Module CARTILAGE MICROTOME MODULE CARTILAGE MICROTOME PHENOL APPLICATOR CARLSON-HAYNES UNIVERSAL RETRACTOR LIPPY BUCKET HANDLE W/NOTCH GRACE MEDICAL TITANIUM/FLUOROPLASTIC PISTON LIPPY BUCKET SANNA PISTON TITANIUM/FLUOROPLASTIC PISTON ROBINSON BUCKET MAZZAWI PISTON DE LA CRUZ PISTON GRACE PISTON MEITI PISTON BARTELS BUCKET HANDLE FLUOROPLASTIC PISTON GRACE MALLEUS PISTON GRACE MEDICAL TITANIUM ROUND WIRE PISTON GRACE MEDICAL FLUOROPLASTIC PISTON TITANIUM PISTON BARTELS BUCKET HANDLE OFFSET ROBINSON BUCKET HANDLE LINSTROM PISTON GRACE BUCKET HANDLE OFFSET SATALOFF MALLEUS PISTON NITINIL SRP ECLIPSE FLAT RIBBON PISTON ECLIPSE MALLEUS PISTON SUPER E PISTON ECLIPSE DE LA CRUZ PISTON ECLIPSE MALLEUS PISTON MODIFIED LOOP ECLIPSE TITANIUM PISTON ECLIPSE PISTON KRAUS K-HELIX PISTON KRAUS K-HELIX CROWN DragonFly BUR, CTR, RD, 80MM L, 1MM , BurShield DragonFly BUR, DMD, RD, 95MM L, 1MM DragonFly BUR, CTR, EGG, 80MM L, 2.3MM , BurShield DragonFly BUR, CTR, RD, 80MM L, 0.7MM , BurShield DragonFly BUR, CTR, EGG, 80MM L, 1.8MM , BurShield DragonFly BUR, DMD, RD, 95MM L, 0.5MM DragonFly BUR, DMD, RD, 95MM L, 2.3MM , BurShield DragonFly BUR, DMD, RD, 95MM L, 1.8MM DragonFly Skinny BUR, 100MM x 0.6MM DragonFly BUR, DMD, RD, 95MM L, 0.6MM DragonFly Skinny BUR, 100MM x 1.4MM DragonFly BUR, DMD, RD, 95MM L, 0.7MM DragonFly BUR, DMD, RD, 95MM L, 2.3MM DragonFly BUR, DMD, RD, 120MM L, 1MM DragonFly BUR, DMD, RD, 100MM L, 1MM , RW DragonFly BUR, CTR, RD, 80MM L, 1.8MM , BurShield DragonFly BUR, DMD, RD, 95MM L, 1MM , BurShield DragonFly BUR, CTR, CYL, 80MM L, 1.8MM , BurShield DragonFly BUR, DMD, RD, 95MM L, 1.4MM DragonFly BUR, DMD, RD, 95MM L, 1.8MM , BurShield DragonFly BUR, CTR, RD, 80MM L, 2.3MM , BurShield DragonFly BUR, DMD, RD, 120MM L, 0.7MM DragonFly BUR, CTR, RD, 80MM L, 0.8MM , BurShield DragonFly Skinny BUR, 100MM x 1MM DragonFly Skinny BUR, 100MM x 0.8MM DragonFly BUR, DMD, RD, 95MM L, 0.4MM DragonFly Skinny BUR,100MM x 0.5MM DragonFly BUR, CTR, RD, 80MM L, 0.5MM , BurShield DragonFly BUR, CTR, RD, 80MM L, 0.6MM , BurShield DragonFly BUR,DMD,RD,100MM L, 0.7MM , RW DragonFly BUR, DMD, RD, 95MM L, 1.4MM , BurShield DragonFly BUR, DMD, RD, 100MM L, 1.4MM , RW DragonFly BUR, CTR, RD, 80MM L, 0.4MM , BurShield DragonFly BUR, CTR, RD, 80MM L, 1.4MM , BurShield DragonFly Skinny BUR, 100MM x 0.7MM DragonFly BUR, DMD, RD, 95MM L, 0.8MM DragonFly BUR, TROCAR PERF, 95MM L, 0.35MM Endoscope MCMENOMEY REVERSE ALLIGATOR FORCEPS SUPERSOFT T-TUBE ARMSTRONG VENT TUBE OWENS ASSURE FRISBEE PARTIAL PRECISE CENTERED PARTIAL 0.5MM L PRECISE OFFSET PARTIAL PRECISE OFFSET PARTIAL 0.5MM L VINCENT TOTAL PRECISE HA LITE TOTAL DB TITANIUM STRUT PRECISE CENTERED TOTAL 1.50MM L WILDCAT FIXED LENGTH TOTAL, HOLLOW WILDCAT FIXED LENGTH TOTAL MIAMI IS COUPLER PARTIAL – LONG WILDCAT PRO, 30MM L WILDCAT PRO, 50MM L WILDCAT PRO, 4.50MM L PRECISE HA LITE PARTIAL DORNHOFFER FOOTPLATE SHOE BOJRAB DUO ALTO TOTAL DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS PRECISE CENTERED TOTAL 20MM L PRECISE BYTE HA FRISBEE PARTIAL PRECISE CENTERED TOTAL BOJRAB FOOTPLATE SHOE MIAMI IS COUPLER PARTIAL – SHORT PRECISE TOTAL WILDCAT PRO, 40MM L WILDCAT PRO, 3.50MM L WILDCAT PRO, 5.50MM L DORNHOFFER PARTIAL 2MM FIXED LENGTH PRECISE CENTERED NYTEBYTE PARTIAL HA WILDCAT FIXED LENGTH TOTAL PRECISE OFFSET TOTAL PRECISE OWENS ASSURE PARTIAL BOJRAB ALTO PRE CUT PRECISE CENTERED PARTIAL DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH K-HELIX FOOTPLATE SHOE PARTIAL TILT TOP 3.50MM HEAD NOTCHED PARTIAL 4MM CENTERED HEAD PARTIAL TILT TOP 3.25MM HEAD OFFSET PARTIAL TILT TOP 4MM HEAD OFFSET TOTAL TILT TOP HEAD NOTCHED STRASNICK TOTAL TILT-TOP 3MM HEAD TOTAL TILT TOP HEAD CENTERED BOJRAB UNIVERSAL UNIVERSAL PROSTHESIS WEHRS DOUBLE NOTCH INCUS WEHRS SINGLE NOTCH INCUS STRANICK PARTIAL TILT-TOP 3MM HEAD PARTIAL 4MM HEAD OFFSET TOTAL TILT TOP HEAD OFFSET PARTIAL 4MM HEAD NOTCHED PARTIAL TILT TOP 4MM HEAD CENTERED WEHRS SINGLE NOTCH INCUS-STAPES WEHRS DOUBLE NOTCH INCUS-STAPES PARTIAL TILT TOP 3.50MM HEAD OFFSET PARTIAL TILT TOP 3.25MM HEAD NOTCHED PARTIAL 3MM CENTERED HEAD PARTIAL TILT TOP HEAD VINCENT TYPE PARTIAL TILT TOP 4MM HEAD NOTCHED TOTAL TILT TOP HEAD VINCENT TYPE PARTIAL TILT TOP 3MM HEAD CENTERED BAXTER BEVELED BOBBIN VENT TUBE ARMSTONG R VENT TUBE ARMSTRONG BEVELED STRAIGHT VENT TUBE MORETZ VENT TUBE W/TAB TINY TEF VENT TUBE SPOON BOBBIN VENT TUBE PEDIATRIC BOBBIN VENT TUBE SIMON/HANNAH BOBBIN VENT TUBE RAZRBAC VENT TUBE GRACE MEDICAL STRAIGHT VENT TUBE MEMPHIS BOBBIN VENT TUBE STRAIGHT VENT TUBE GRAACE MEDICAL T-TUBE SHEPARD GROMMET TOUMA VENT TUBE W/TAB

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Reprocess Single-Use Device Develop Specifications But Do Not Manufacture At This Facility