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

Wellesley, MA, US

Satelec appears in FDA device records in Wellesley, MA. FDA records list 24 510(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
24
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 24 510(k) clearances for Satelec between 1990 and 2011. The busiest year on record is 2004, with 4. The most recent is 2011, with 1.

Clearances by year, as a table
510(k) clearance decisions for Satelec, by decision year
YearClearances
19901
19951
19962
19972
20001
20011
20031
20044
20051
20063
20072
20081
20092
20101
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K110379AIR-N-GOEFBSubstantially Equivalent
K100410PIEZOELECTRIC SYSTEMJDXSubstantially Equivalent
K091331PIEZOTOME 2DZISubstantially Equivalent
K091252IMPLANT CENTER 2DZISubstantially Equivalent
K082116HEMOSTASYL PASTEMVLSubstantially Equivalent
K072181MINI LED AUTOFOCUSEBZSubstantially Equivalent
K071965I-SURGEEFBSubstantially Equivalent
K060275PIEZOTOMEELCSubstantially Equivalent
K060274PIEZOTOMEDZISubstantially Equivalent
K053328BIOSPLINT SPLINTING RIBBONEBISubstantially Equivalent
K050895SURPASSON P5 NEWTRONELCSubstantially Equivalent
K042787IS 40 MICROMOTOREFBSubstantially Equivalent
K040529COCOON HYGIENISTEIASubstantially Equivalent
K040808MINI L.E.D. OEM MODULEEBZSubstantially Equivalent
K033764SP NEWTRON MODULEELCSubstantially Equivalent
K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIEBZSubstantially Equivalent
K011001TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEMLWMSubstantially Equivalent
K000049SUNI MAXEFBSubstantially Equivalent
K972612DISSECTRON PORTABLE UNITLBKSubstantially Equivalent
K972026SP4044 & SP4055 LUX MODULESELCSubstantially Equivalent
K961735ACTAEBZSubstantially Equivalent
K961158SUPRASSON P5 BOOSTERELCSubstantially Equivalent
K942139SUPRASSON P MAXELCSubstantially Equivalent
K904067LASERSAT CO2GEXSubstantially 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