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

Mchenry, IL, US

Cutter Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 39 510(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
39
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 39 510(k) clearances for Cutter Laboratories, Inc. between 1976 and 1986. The busiest year on record is 1977, with 10. The most recent is 1986, with 2.

Clearances by year, as a table
510(k) clearance decisions for Cutter Laboratories, Inc., by decision year
YearClearances
19768
197710
19784
19793
19806
19822
19832
19842
19862
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K861315HYPERBARIC PENETRATION EXTENSION SETCBFSubstantially Equivalent
K854106BAYSILEXELWSubstantially Equivalent
K842324PERFOURMELWSubstantially Equivalent
K834106INTRAVENOUS INFUSION CONTROLLERLDRSubstantially Equivalent
K832237ORTHOPEDIC CASTING TAPE MAXCASTITGSubstantially Equivalent
K823214DOSIMETRIC RELEASE PROGRAM - ADMIN. SETFPASubstantially Equivalent
K821326CUTTER BOND POLYCARBOXYLATE CEMENTEMASubstantially Equivalent
K813532CUTTERBOND ZINC PHOSPHATE CEMENTEMASubstantially Equivalent
K802105C-BLADEHWESubstantially Equivalent
K802104C-SPLINTIQISubstantially Equivalent
K801652TOTAL PARENTERAL NUTRITION SET BAGKPESubstantially Equivalent
K801651CUTTER JETEFBSubstantially Equivalent
K800213PHARMACY ADDITIVE SYRINGE SETKYWSubstantially Equivalent
K792250CUTTER POINTSEHLSubstantially Equivalent
K792207PERIDIAL PERITONEAL DIALYSIS TRAYFKGSubstantially Equivalent
K790125ULNAR HEAD PROTHESISKXESubstantially Equivalent
K781937PROTHESIS, METACARPALSubstantially Equivalent
K781521CUTTER RESIFLEX URINE METERKNXSubstantially Equivalent
K781668GAMMA RADIATION STERILIZATION PRECEDUREKYJSubstantially Equivalent
K781059CUTTER/COMPUR MINI CENTRIFUGEGKFSubstantially Equivalent
K780624CULDOCENTESIS TRAYGAASubstantially Equivalent
K772225PATELLAR PROSTHESISJWHSubstantially Equivalent
K770776TRAY, PRESSURE, INTRACOMPARTMENTAL,WICKSubstantially Equivalent
K770751CATHETERS, OVER-THE-NEEDLEFOZSubstantially Equivalent
K770678ELC-THERMO-SYSTEMKXZSubstantially Equivalent
K770742CUTTER CAST 7ITGSubstantially Equivalent
K770619EXERCISOR, RESPIRATORYBWFSubstantially Equivalent
K770469CUTTER TUNGSTEN CARBIDE BURSEJLSubstantially Equivalent
K770392MUFFLER, AIR PUMPCAHSubstantially Equivalent
K770376FILTER, NEBULIZER, CUTTERCAHSubstantially Equivalent
K770375FILTER, AIR, CUTTER MAINLINECAHSubstantially Equivalent
K760753CUTTER JEL-ALGINATE IMPRESSION MAT.ELWSubstantially Equivalent
K760755CUTTER SIL-SILICONE IMPRESSION MATELWSubstantially Equivalent
K760754CUTTER TRAY-ACRYLIC FOR IMP TRAYSEBHSubstantially Equivalent
K760752CUTTER FLEX-SILICONE IMPRESSION MAT.ELWSubstantially Equivalent
K760744TAVERNETTI-TENNANTHRYSubstantially Equivalent
K760422SURGICAL RETRACTORGADSubstantially Equivalent
K760236BUR, SURGICAL CARBIDEHTTSubstantially Equivalent
K760235SUTURE GUIDESubstantially 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

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