Grace Medical Group Inc

FDA Filings

This page includes the latest FDA filings for Grace Medical Group Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2021687
FEI Number2021687
NameOTO-MED, INC.
Owner & OperatorGRACE MEDICAL GROUP, INC.
Contact Address8500 Wolf Lake Drive Suite 110
Memphis TN 38133 US
Official Correspondent
  • Murray L Beard
  • x-901-3860990-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1090 Empire Dr.
Lake Havasu City, AZ 86404 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



Registration Number1057421
FEI Number1000022662
NameGRACE MEDICAL, INC.
Owner & OperatorGRACE MEDICAL GROUP, INC.
Contact Address8500 WOLF LAKE DR. SUITE 110
Memphis TN 38133 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address8500 WOLF LAKE DR. SUITE 110
Memphis, TN 38133 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
EndoEar2019-12-06
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
DragonFly Drill System Attachments2018-09-20
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
DragonFly Batteries and Seal Kit2018-09-18
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Phenol Applicator2018-09-18
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Glasscock Otology Surgical Drape, Glasscock Neurotology Surgical Drape2018-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Carlson-Haynes Universal Retractor2017-12-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
McMenomey Reverse Alligator Forceps2017-12-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Elevator2017-12-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Ear Knife2017-12-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Cartilage Microtome2017-12-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Suctions2017-04-06
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Suction Adapter2017-04-06
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
spineX Bone Dust Collector2017-02-09
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
DragonFly Bur2016-12-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
DragonFly2016-08-26
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wehrs2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Vincent2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Strasnick2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Otosil2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Otosil Tilttop2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bojrab2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wehrs2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Vincent2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Strasnick2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Otosil2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Otosil Tilttop2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bojrab2015-10-10
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Triune2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Triune Trumpent2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Touma2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Tiny Triune2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Tapervent2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
T-Tube2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Shepard Grommet2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy Collar Button2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Shea Parasol2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Rube2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Pope2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Paparella2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Modified T-Tube2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Mini-Reversible2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Donaldson2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Collar Button2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Canoe2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstrong R2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Tiny Tef2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Straight Tube2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Spoon Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Simon Hannah Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Shepard Grommet2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy Collar Button2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Reuter Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Razrbac2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Pediatric Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Paparella2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Moretz2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Memphis Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Donaldson2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Baxter Beveled Straight2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstrong R2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstrong Beveled Bobbin2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Pope Bevel Grommet2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Modified Armstrong Grommet2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstrong Bevel Grommet2015-10-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Endoscopic Instrument Tray2015-09-06
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT TOP OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT TOP CENTERED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
STRASNICK TOTAL TILT-TOP2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
STRASNICK PARTIAL TILT-TOP2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP CENTERED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Total Centered2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA TOTAL OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA TOTAL NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Partial Centered2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL STRUT2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA FOOTPLATE SHOE2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT TOP OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT TOP CENTERED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
TOTAL TILT NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
STRASNICK TOTAL TILT-TOP2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
STRASNICK PARTIAL TILT-TOP2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
PARTIAL TILT TOP CENTERED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Total Centered2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA TOTAL OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA TOTAL NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Partial Centered2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL STRUT2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL OFFSET2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA PARTIAL NOTCHED2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA FOOTPLATE SHOE2015-09-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Sterilization Trays2014-11-05
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Super E Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Eclipse Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Eclipse De la Cruz Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sataloff Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sanna Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Robinson Bucket2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
NYEEI Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
MEITI Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Lippy Bucket2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Bucket2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
De la Cruz Piston2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bartels Bucket2013-10-23
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Kraus K-Helix Piston2013-08-17
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Kraus K-Helix Crown2013-08-17
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
SafeTrap Collector2013-07-03
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy Bone Dust Collector: Cox Bone Dust Collector2008-03-18
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Head & Neck Pressure Dressing2008-03-18
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Glasscock Ear Dressing Adult and pediatric size2008-03-18
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Triune Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Tiny Triune Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Tapervent Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
T-Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Rube Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Pope Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Paparella Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
MEI Pediatric Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Donaldson Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstong R Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Shepard Grommet Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy Collar Button Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Reuter Bobbin Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Beveled Bobbin Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Armstrong R Vent Tube2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wehrs Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wedge Incus Strut2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Vincent ALTO with Band2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Silverstein ALTO Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sataloff ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Precise Totals and Partials2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Precise HA Lite Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Owens Assure ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Nano ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Moretz ALTO Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Haberman ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Lite ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical ALTO Byte Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Frisbee Partials2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Duo ALTO Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Dornhoffer ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bojrab ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wehrs Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Wedge Incus Strut2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Vincent ALTO with Band2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Silverstein ALTO Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Sataloff ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Precise Totals and Partials2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Precise HA Lite Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Owens Assure ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Nano ALTO Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Moretz ALTO Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Haberman ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
HA Lite ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical ALTO Byte Partial and Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Frisbee Partials2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Duo ALTO Total2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Dornhoffer ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Bojrab ALTO Partials and Totals2007-10-30
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Sterilization Tray2006-11-14
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
FeatherVac Stapes Seat2006-07-24
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Dissector2006-07-24
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
AccuTip2006-07-24
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
ALTO Cutter2006-07-24
GRACE MEDICAL, INC. [GRACE MEDICAL GROUP, INC.]
Grace Medical Measuring Rods2006-07-24
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Otomed Suction Tubing2006-04-12
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
LEVINE IRRIGATION-SUCTION KIT2006-04-12
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
Sheehy-House Powder Insufflator2006-03-17
OTO-MED, INC. [GRACE MEDICAL GROUP, INC.]
POWDER INSUFFLATOR2006-03-17

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