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

Mchenry, IL, US

Mallinckrodt Critical Care appears in FDA device records in Mchenry, IL. FDA records list 92 510(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
92
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 92

FDA records hold 92 510(k) clearances for Mallinckrodt Critical Care between 1976 and 1989. The busiest year on record is 1977, with 16. The most recent is 1989, with 1.

Clearances by year, as a table
510(k) clearance decisions for Mallinckrodt Critical Care, by decision year
YearClearances
19764
197716
19786
19794
19808
19818
19827
198311
19847
19857
19865
19875
19883
19891
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K880343BURNEY GALLBLADDER CATHETER KITFGESubstantially Equivalent
K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORKRISubstantially Equivalent
K874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEFLLSubstantially Equivalent
K874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORFLLSubstantially Equivalent
K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORFLLSubstantially Equivalent
K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)BTRSubstantially Equivalent
K873833THERMOCOUPLE ADAPTERFLLSubstantially Equivalent
K873004GUIDING CATHETERDQOSubstantially Equivalent
K871204CUFFED TRACHEAL TUBE (MULTIPLE)BTRSubstantially Equivalent
K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)BTRSubstantially Equivalent
K862653LUER LOCK ADAPTER/NUTFPASubstantially Equivalent
K860901LASER RESISTANT TRACHEAL TUBE (TENTATIVE)BTRSubstantially Equivalent
K861483ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)DQOSubstantially Equivalent
K853182DIAGNOSTIC INTRAVASCULAR CATHETERSDQOSubstantially Equivalent
K852413LGT TUBEBTOSubstantially Equivalent
K852025BRANDT TRACHEAL TUBE(TENTATIVE)BTRSubstantially Equivalent
K852493UNCUFFED HI-LO JET TRACHEAL TUBEBTRSubstantially Equivalent
K845037PERCUTANEOUS ANGIOGRAPHIC NEEDLESDYBSubstantially Equivalent
K844201HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTORFLLSubstantially Equivalent
K844598LARIAT CATHETERDQOSubstantially Equivalent
K843640XENON XE 127/XE 133 GAS DISPENSERIYTSubstantially Equivalent
K841872UNCUFFED REINFORCED TRACHEAL TUBEBTRSubstantially Equivalent
K842113AMENDMENT TO ANGIOGRAPHY KIT W/ADDITDRESubstantially Equivalent
K842464TRACHEAL TUBE/STETHOSCOPEBTRSubstantially Equivalent
K842011CHLORIDE TEST KITCHJSubstantially Equivalent
K840399FOAM NOSEBYDSubstantially Equivalent
K840398INLINE FOAM NOSEBYDSubstantially Equivalent
K834223CARDIOVASCULAR SPRING GUIDE WIREDQXSubstantially Equivalent
K832657DISPOSABLE MANIFOLD SETDRSSubstantially Equivalent
K832635HI-LO TEMP TYMPANIC TEMP. SENSORFLLSubstantially Equivalent
K832553POTASSIUM TEST KITCEJSubstantially Equivalent
K832552SODIUM TEST KITCEISubstantially Equivalent
K832288HEMOGLOBINOMETERKMGSubstantially Equivalent
K831567FOLEY-TEMPKODSubstantially Equivalent
K831509ANGIOGRAPHY KIT W/ADDIT. COMPONENTSDQOSubstantially Equivalent
K830631TRACHEAL TUBE W/ILLUMINATING LOCATERBTRSubstantially Equivalent
K830415DIAGNOSTIC INTRAVASCULAR CATHETERDQOSubstantially Equivalent
K830229ROENTGENOGRAPHY SETDGDSubstantially Equivalent
K823886PROFILE 750 BLOOD CELL COUNTERGKLSubstantially Equivalent
K822159ANGIOUROGRAPHY KITFMFSubstantially Equivalent
K822640CORONARY INFUSION KITDQOSubstantially Equivalent
K821151RIA-QUANT FPA TEST KITDANSubstantially Equivalent
K821976ANGIOGRAPHY KITDQOSubstantially Equivalent
K821833HI-LO TEMP SKIN TEMPERATURE SENSORFLLSubstantially Equivalent
K820725SPAC T4 RIA TEST KITCDXSubstantially Equivalent
K820001CORONARY INFUSION KITDQOSubstantially Equivalent
K812690C-PEPTIDE CONTROL PACKJJXSubstantially Equivalent
K812689RIA QUANT C-PEPTIDE KITJKDSubstantially Equivalent
K812000PEDIATRIC DOUBLE SWIVEL CONNECTORBZASubstantially Equivalent
K811888LINDHOLM ANATOMICAL TRACHEAL TUBEBTRSubstantially 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.

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