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

DALTON INDUSTRIAL PARK, P.O BOX 9 Northern, IL

ELCAM MEDICAL A.C.A.L. appears in FDA device records in DALTON INDUSTRIAL PARK, P.O BOX 9 Northern, IL. FDA records list 16 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 16 510(k) clearances for Elcam Medical A.C.A.L. between 2003 and 2023. The busiest year on record is 2006, with 3. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Elcam Medical A.C.A.L., by decision year
YearClearances
20031
20041
20063
20081
20101
20111
20123
20131
20141
20191
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231900A-TAP (previously called Arthrotap)FMFSubstantially Equivalent
K211204SafePort(TM) Manifold (or Stopcock)FMGSubstantially Equivalent
K190489Elcam Stopcocks and ManifoldsFMGSubstantially Equivalent
K141254ELCAM STOPCOCKS AND MANIFOLDSFMGSubstantially Equivalent
K123084DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLDFMGSubstantially Equivalent
K120253ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)DRGSubstantially Equivalent
K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)DRSSubstantially Equivalent
K111467FLEXI-Q DV AND DVR AUTO-INJECTORSKZHSubstantially Equivalent
K111016SAFEPORT MANIFOLD (TM) (OR STOPCOCK)FPASubstantially Equivalent
K100425HASKAL TORQUE DEVICEDQXSubstantially Equivalent
K082106ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)FMGSubstantially Equivalent
K060759Y-CLICK CONNECTORDTLSubstantially Equivalent
K053405BACSTOPFMGSubstantially Equivalent
K060231CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCKFMGSubstantially Equivalent
K034043H-FLOW VALVEDQOSubstantially Equivalent
K032393INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)FMGSubstantially Equivalent

Registered establishments

FDA registered establishments for Elcam Medical A.C.A.L., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96121523002806901ELCAM MEDICAL A.C.A.L.KIBBUTZ BAR-AM, D.N. MEROM HAGALIL Northern 1386000 IL2026
30068916653006891665ELCAM MEDICAL ACALD.N. MEROM HAGALIL, DALTON INDUSTRIAL PARK, P.O BOX 9 Northern 1381000 IL2026

Registration numbers link to the FDA registration and listing record for that establishment.

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