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

Middleton, MA, US

Mercury Medical appears in FDA device records in Middleton, MA. FDA records list 16 510(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
16
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 16 510(k) clearances for Mercury Medical between 1994 and 2014. The busiest year on record is 1996, with 4. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Mercury Medical, by decision year
YearClearances
19941
19964
19971
20002
20021
20032
20041
20092
20101
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142096T-PIECE RESUSCITATORBTLSubstantially Equivalent
K093913MERCURY MEDICAL T-PIECE RESUSCITATORBTLSubstantially Equivalent
K090710MERCURY CPAPBYESubstantially Equivalent
K083056NEO-STAT CO2 <KGCCKSubstantially Equivalent
K032593MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETERBXRSubstantially Equivalent
K031814STATCO2METER, MODEL 10-55372CCKSubstantially Equivalent
K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371CCKSubstantially Equivalent
K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370CCKSubstantially Equivalent
K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149NHKSubstantially Equivalent
K000073MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULAGXISubstantially Equivalent
K970756MERCURY MEDICAL REUSABLE CPR BAGBTMSubstantially Equivalent
K954492MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEXBWFSubstantially Equivalent
K954490MERCURY MEDICAL CPR BAG EXHALATION FILTERCAHSubstantially Equivalent
K954486MERCURY AIRWAY PRESSURE MANOMETERCAPSubstantially Equivalent
K954866MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIRBTMSubstantially Equivalent
K945901DIRECT VIEW 2001 FIBERLIGHTCCWSubstantially 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