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

Potomac, MD, US

New Deal, S.A. appears in FDA device records in Potomac, MD. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
28
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 28 510(k) clearances for New Deal, S.A. between 1999 and 2007. The busiest year on record is 2001, with 5. The most recent is 2007, with 3.

Clearances by year, as a table
510(k) clearance decisions for New Deal, S.A., by decision year
YearClearances
19994
20003
20015
20023
20041
20054
20065
20073
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K070241MODIFICATION TO LAPIDUS PLATEHRSSubstantially Equivalent
K070160MODIFICATION TO TTC PLATESHRSSubstantially Equivalent
K063820LISFRANC PLATEHRSSubstantially Equivalent
K060474LISFRANC PLATEHRSSubstantially Equivalent
K061765KALIX II IMPLANTHWCSubstantially Equivalent
K061594LARGE UNI-CLIP STAPLEJDRSubstantially Equivalent
K060476LAPIDUS PLATEHRSSubstantially Equivalent
K060473TTC PLATEHRSSubstantially Equivalent
K053093KALIX II IMPLANT, MODEL 141 0XX WITH XXHWCSubstantially Equivalent
K052152B-BOP PLATEHRSSubstantially Equivalent
K050882NEWDEAL ANKLE NAILHSBSubstantially Equivalent
K050346STABILIZATION SCREWHWCSubstantially Equivalent
K041786CALCAMEA PLATEHRSSubstantially Equivalent
K022597K-FIXHTYSubstantially Equivalent
K022599NEWDEAL K WIREHTYSubstantially Equivalent
K021626HALLU PLATESHRSSubstantially Equivalent
K011875MODIFICATION TO THE TAC' PINJDWSubstantially Equivalent
K011821MODIFICATION TO THE I.C.O.S SCREWHWCSubstantially Equivalent
K011716THE UNI-CLIP STAPLEJDRSubstantially Equivalent
K011946THE SPIN SNAP-OFF SCREWHWCSubstantially Equivalent
K011262MODIFICATION TO THE BOLD SCREWHWCSubstantially Equivalent
K001231THE KALIX IMPLANTHWCSubstantially Equivalent
K993762I.CO.S SCREWHWCSubstantially Equivalent
K993910TAC' PINJDWSubstantially Equivalent
K991566SOLUSTAPLEJDRSubstantially Equivalent
K991477SPIN SNAP-OFF SCREWHWCSubstantially Equivalent
K991482UNI-CLIP STAPLEJDRSubstantially Equivalent
K990622BOLD SCREWHWCSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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