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

Savannah, GA, US

INNOMED, INC. appears in FDA device records in Savannah, GA. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Innomed, Inc. between 1982 and 1987. The busiest year on record is 1982, with 2. The most recent is 1987, with 1.

Clearances by year, as a table
510(k) clearance decisions for Innomed, Inc., by decision year
YearClearances
19822
19871
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K872747LASER CENTERING DEVICEHMRSubstantially Equivalent
K822574INNOMED PD-1 KITLJLSubstantially Equivalent
K827796INNOSCAN EXAMINATION LIGHTSubstantially Equivalent

Registered establishments

FDA registered establishments for Innomed, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18330531833053INNOMED, INC.103 Estus Dr, SAVANNAH, GA 31404 US2026and 38 more, listed in full below
30454944023045494402INNOMED, INC.1130 Taylor St, N Manchester, IN 46962 US2026

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-1753-2024INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.Class IICompleted

Verification record

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