GRACE MEDICAL, INC.

FDA Device Registration & Listing · Memphis, TN, US · Registration 1057421

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1057421
FEI Number
1000022662
Entity Name
GRACE MEDICAL, INC.
City/State/Country
Memphis, TN, US
Establishment Address
8500 WOLF LAKE DR. SUITE 110, Memphis, TN 38133, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GRACE MEDICAL GROUP, INC. (Owner Number: 9067138)
Owner / Operator Contact Address
8500 WOLF LAKE DR., SUITE 110, Memphis, TN 38133, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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 Grace Medical 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 Endo Ear BOJRAB DISSECTION ROUND KNIFE, 2.54MM DIA BOJRAB DISSECTION ROUND KNIFE, 2.5MM DIA BOJRAB DISSECTION SICKLE KNIFE Endo Ear CARTILAGE MICROTOME STERILIZATION TRAY Endo Ear 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 Endo Ear 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 OtoMed SHEEHY COLLAR BUTTON VENT TUBE 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 DONALDSON VENT TUBE Vent Tube TRIUNE TRUMPET VENT TUBE TINY TRIUNE VENT TUBE BOJRAB TINY TRIUNE PAPARELLA VENT TUBE SHEPARD GROMMET VENT TUBE TOUMA VENT TUBE W/ TAB SHEA PARASOL VENT TUBE W/TAB ARMSTRONG R VENT TUBE CANOE VENT TUBE TAPERVENT TUBE PAPARELLA VENT TUBE W/TAB POPE VENT TUBE CARTILAGE MICROTOME HANDLE Cartilage MACROTOME Tissue Support Endo Ear TISSUE SUPPORT DIAL Cartilage MACROTOME Handle Cartilage MACROTOME Module CARTILAGE MICROTOME MODULE CARTILAGE MICROTOME Endo Ear PHENOL APPLICATOR CARLSON-HAYNES UNIVERSAL RETRACTOR Endo Ear LIPPY BUCKET HANDLE W/NOTCH GRACE MEDICAL TITANIUM/FLUOROPLASTIC PISTON LIPPY BUCKET SANNA PISTON TITANIUM/FLUOROPLASTIC PISTON ROBINSON BUCKET Grace Medical 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 OtoMed 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 Grace Medical ECLIPSE PISTON Grace Medical KRAUS K-HELIX PISTON KRAUS K-HELIX CROWN OtoMed Endo Ear OtoMed 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 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 Endo Ear POPE VENT TUBE SUPERSOFT T-TUBE Vent Tube MODIFIED ARMSTRONG GROMMET

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2025-02-13
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2006-07-24
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2015-09-05
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2015-09-05
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2007-10-30
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2016-08-26
JYO Knife, Ear Ear, Nose, Throat Class 1 874.4420 2017-12-14
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2006-11-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2015-09-06
JYJ Gauge, Measuring Ear, Nose, Throat Class 1 874.4420 2006-07-24
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2017-04-06
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2025-02-13
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2015-10-05
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2017-12-14
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2018-09-18
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2017-12-14
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2013-10-23
MHW Dressing, Compression General Hospital Class 1 880.5075 2025-02-13
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2013-10-23
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2013-08-17
MXP Bone Particle Collector Ear, Nose, Throat Class 1 874.4800 2025-02-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-11-05
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2025-02-12
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2016-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2019-12-06
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2017-12-14
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2015-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GRACE MEDICAL GROUP, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1057421. Last updated year: 2026. Please use registration number 1057421 when referencing this establishment in official correspondence.
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