510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Grace Medical, Inc.

Memphis, TN, US

GRACE MEDICAL, INC. appears in FDA device records in Memphis, TN. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Grace Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Eagle Vision, Inc.510(k), recall

510(k) clearance history

FDA records hold 21 510(k) clearances for Grace Medical, Inc. between 1988 and 2023. The busiest year on record is 2006, with 6. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Grace Medical, Inc., by decision year
YearClearances
19881
19892
19911
19941
19961
19971
19981
19992
20031
20066
20081
20091
20161
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232059Tympanostomy TubesETDSubstantially Equivalent
K161376DragonFly Surgical Drill SystemERLSubstantially Equivalent
K091187GRACE DYNAMIC TORPETASubstantially Equivalent
K080070K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESETBSubstantially Equivalent
K063374NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOEETBSubstantially Equivalent
K062672GRACE MEDICAL PC COATED TYMPANOSTOMY TUBESETDSubstantially Equivalent
K062385BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBESETDSubstantially Equivalent
K061853GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESESETBSubstantially Equivalent
K060518PARTIAL OSSICULAR REPLACEMENT PROSTHESESETBSubstantially Equivalent
K053333EAGLEVISION GELLANSERTS, MODEL REF 0040LZUSubstantially Equivalent
K030353MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETSOKSSubstantially Equivalent
K991394STAPES PROSTHESESETBSubstantially Equivalent
K991130FLEXPLUGLZUSubstantially Equivalent
K981575TYMPANOSTOMY TUBEETDSubstantially Equivalent
K972815PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENTETBSubstantially Equivalent
K963752PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESISETBSubstantially Equivalent
K943325TYMPANOSTOMY TUBEETDSubstantially Equivalent
K905427EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUGLZUSubstantially Equivalent
K890919TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTLZUSubstantially Equivalent
K890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVELZUSubstantially Equivalent
K883233EV MONOCANALICULAR STENT (TM)OKSSubstantially Equivalent

Registered establishments

FDA registered establishments for Grace Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10574211000022662GRACE MEDICAL, INC.8500 WOLF LAKE DR. SUITE 110, Memphis, TN 38133 US2026and 15 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2308-2026TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes ProsthesisDue to incorrect functional length on device labeling.Class IIOpen, Classified
Z-0847-06Valve-EV Glaucoma Ultra-Smooth, P/N 6006Product may have deformed valves which would cause the valve not to operate properly.Terminated
Z-0846-06Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365VProduct may have deformed valves which would cause the valve not to operate properly.Terminated
Z-0845-06Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209VProduct may have deformed valves which would cause the valve not to operate properly.Terminated
Z-0844-06Krupin Eye Valve, P/N 6003Product may have deformed valves which would cause the valve not to operate properly.Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain