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

Mchenry, IL, US

Suncoast Medical Manufacturers, Inc. appears in FDA device records in Mchenry, IL. FDA records list 31 510(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
31
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 31 510(k) clearances for Suncoast Medical Manufacturers, Inc. in 1984.

Clearances by year, as a table
510(k) clearance decisions for Suncoast Medical Manufacturers, Inc., by decision year
YearClearances
198431
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K841604ADJUST-A-TEMP HIGH TEMPERATUREGEISubstantially Equivalent
K841603ADJUST-A-TEMP MICROGEISubstantially Equivalent
K841509REPLACE-A-TIP ADJUSTABLE HIGH TEMP.GEISubstantially Equivalent
K841459REPLACE-A-TIP ADJUST. LOW TEMP.-GEISubstantially Equivalent
K841591PYRO-TIPGEISubstantially Equivalent
K840376SURG-A STAT LOOP TIPGEISubstantially Equivalent
K840387SURG-A-STAT LOOP TIP 2GEISubstantially Equivalent
K840377SURG-A-STAT CARDIOVASCULAR TIPGEISubstantially Equivalent
K840375SURG-A-STAT LOOP TIP 15GEISubstantially Equivalent
K840370SURG-A-STAT VASECTOMY TIPGETSubstantially Equivalent
K841589C-LITEKYTSubstantially Equivalent
K841588SUN-LITE WHITE SPOTKYTSubstantially Equivalent
K841326REPLACE-A-TIP RECHARGEABLE HIGH TEMPHQPSubstantially Equivalent
K841325REPLACE-A-TIP RECHARG. LOW TEMP.HQPSubstantially Equivalent
K840492SUN-LITE BLUE SLITHTPSubstantially Equivalent
K840430SUN-LITE WHITE SLITSubstantially Equivalent
K840428SUN-LITE PEN LIGHTSubstantially Equivalent
K840427SUN-LITE BLUE SPOTSubstantially Equivalent
K840426OPTHERM EXTRA FINE TIPHQPSubstantially Equivalent
K840425OPTHERM FINE TIPHQPSubstantially Equivalent
K840434REPLACE-A-TIP LOW TEMP. CAUTERYGEISubstantially Equivalent
K840433REPLACE-A-TIP HIGH TEMP. CAUTERYGEISubstantially Equivalent
K840373FLEXIBLE ILLUMINATOR 10FTFSubstantially Equivalent
K840372FLEXIBLE ILLUMINATOR 15FTFSubstantially Equivalent
K840371FLEXIBLE ILLUMINATOR 5FTFSubstantially Equivalent
K840585SURG-A-STAT FINE TIP 2GEISubstantially Equivalent
K840493SURG A STAT FINE TIP 5Substantially Equivalent
K840456SUN-LITE 1Substantially Equivalent
K840429SUN-LITE ONE MILLIMETERSubstantially Equivalent
K840378ADJUST-A-TEMP EXTRA FINE TIPUnknown
K840374SURG-A-STAT FINE TIPUnknown

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