Simplivia Healthcare Ltd.

KIRYAT SHMONA Northern, IL

SIMPLIVIA HEALTHCARE LTD. appears in FDA device records in KIRYAT SHMONA Northern, IL. FDA records list 22 510(k) clearances between 1985-08-22 and 2025-10-21, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 22
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Simplivia Healthcare Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Migada, Ltd.510(k), recall

510(k) clearance history

FDA records hold 22 510(k) clearances for Simplivia Healthcare Ltd. between 1985 and 2025. The busiest year on record is 1986, with 7. The most recent is 2025, with 2.

Clearances by year, as a table

510(k) clearance decisions for Simplivia Healthcare Ltd., by decision year
Year	Clearances
1985	3
1986	7
1987	2
1990	1
1993	1
1994	1
1996	1
2020	1
2021	2
2023	1
2025	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253033	Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor	ONB	Substantially Equivalent	2025-10-21
K251411	Chemfort Female Luer Lock Adaptor	ONB	Substantially Equivalent	2025-08-05
K231286	Chemfort® Catheter Adaptor	ONB	Substantially Equivalent	2023-08-02
K210707	OnGuard2 Chemfort Closed Administration (CADM)	ONB	Substantially Equivalent	2021-09-23
K201142	TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set	ONB	Substantially Equivalent	2021-02-25
K192866	Chemfort CSTD	ONB	Substantially Equivalent	2020-05-07
K954883	FREE FLOW SAFETY DEVICE	FPA	Substantially Equivalent	1996-04-23
K943095	IV TRANSFER SPIKE	LHI	Substantially Equivalent	1994-09-30
K933929	LAB-SITE(R) SAFETY CANNULA	CBF	Substantially Equivalent	1993-12-07
K902881	LAB-SITE SAFETY NEEDLE	CBT	Substantially Equivalent	1990-09-26
K870016	ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)	DTB	Substantially Equivalent	1987-05-28
K864453	EMERGENCY & MILITARY INFUSION SYSTEM	FPA	Substantially Equivalent	1987-01-20
K863304	PRESELECTED FLOW RATE I.V. SET	FPA	Substantially Equivalent	1986-12-09
K860952	I.V. SET WITH AND WITHOUT AIR VENT	FPA	Substantially Equivalent	1986-08-27
K861275	HIGH FLOW I.V. SET	FPA	Substantially Equivalent	1986-06-02
K860595	TRANSFER SET	LHI	Substantially Equivalent	1986-04-07
K860605	FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER	FPA	Substantially Equivalent	1986-03-24
K854365	IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS	FPA	Substantially Equivalent	1986-03-24
K860201	PARENTERAL ADMINISTRATION SET	FPA	Substantially Equivalent	1986-02-04
K853385	I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT	FPA	Substantially Equivalent	1985-08-23
K853387	ET - EXTENSION SETS	FPA	Substantially Equivalent	1985-08-22
K853386	MULTISET 40	BRZ	Substantially Equivalent	1985-08-22

Registered establishments

FDA registered establishments for Simplivia Healthcare Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9611423	3002807615	SIMPLIVIA HEALTHCARE LTD.	NORTH IND. ZONE P.O.BOX 888, KIRYAT SHMONA Northern 1101801 IL	2026	FPA ONB

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1057-2022	OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143	Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.	Class II	2022-03-08	Open, Classified
Z-1244-2009	TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device.	Syringe adaptor is disintegrating when attached to the end of the syringe.		2008-12-18	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain