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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2025-02-13 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2006-07-24 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2015-09-05 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2015-09-05 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2007-10-30 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2016-08-26 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2017-12-14 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2006-11-14 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2015-09-06 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2006-07-24 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2017-04-06 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2025-02-13 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2017-12-14 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2018-09-18 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2017-12-14 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2025-02-13 |
| Bone Particle Collector | MXP | Class 1 | Ear, Nose, Throat | No | 2025-02-13 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2025-02-12 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2016-12-10 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2019-12-06 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2017-12-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2025-02-13 |
| Blower, Powder, Ent | KCL | Class 1 | Ear, Nose, Throat | No | 2025-02-13 |
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