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Oscor Inc.

Last updated September 17, 2026

Information

Country: US
Address: 4875 Palm Harbor Blvd, PALM HARBOR, FL, 34683
Website: oscor.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(727)937-2511
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1035166
DUNS Number: 101835833

Catalogue (1244)

Page 4 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Sigma	ASG1002335	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0857717	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 66 C	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08016B5	FDA UDI	Class II	Active
Adelante Sigma	ASG11023	FDA UDI	Class II	Active
Adelante® Breezeway®	AB1061FT	FDA UDI	Class II	Active
SafeSheath® II	SS6	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0500	FDA UDI	Class II	Active
Adelante Sigma	ASG1201035	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0276	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007722	FDA UDI	Class II	Active
Adelante Breezeway	AB101075	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1357125NM	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0856722	FDA UDI	Class II	Active
Adelante S	ASUL1123B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0089	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0289	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0305	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0857317	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0805	FDA UDI	Class II	Active
Adelante Breezeway	AB073004	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0252	FDA UDI	Class II	Active
Tb	020001	FDA UDI	Class II	Unknown
Adelante SafeSheath Ultra Lite	ASUP081318P	FDA UDI	Class II	Active
Ls14b20	LS14B20	FDA UDI	Class III	Active
SafeSheath® II	667473-300	FDA UDI	Class II	Active
Adelante Breezeway	AB063003	FDA UDI	Class II	Active
Atar	53912D	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG506-0405	FDA UDI	Class II	Active
iLINK-BLV-10	iLINK-BLV-10	FDA UDI	Class II	Active
Helios	HK05110S	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 61 S	FDA UDI	Class II	Active
SafeSheath® Ultra	SUL11	FDA UDI	Class II	Active
Adelante Breezeway	AB081046	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP071318P	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0854522	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG070110045	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856122GW	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12023P	FDA UDI	Class II	Active
Adelante Breezeway	AB083000	FDA UDI	Class II	Active
Guidestar™ Steerable Guiding Sheath	D141103	FDA UDI	Class II	Active
Occlutech Delivery Set III	98US006	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21106	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856750GW	FDA UDI	Class II	Active
Tb	TBK06110SSG	FDA UDI	Class II	Unknown
Adelante Sigma	ASG11023P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0656509	FDA UDI	Class II	Active
Adelante Sigma	ASG06010W	FDA UDI	Class II	Active
Pace 203h	PACE 203H	FDA UDI	Class II	Active
Tb	020003	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 22, 2021	Z-0646-2022	—	completed	There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Mar 10, 2021	Z-1329-2021	—	terminated	Potential for open seal on sterile product
Sep 26, 2018	Z-0391-2019	—	terminated	During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Mar 31, 2017	Z-2340-2017	—	terminated	The Reusable Oscor ATAR extension cables could separate from the connector during use.
Mar 31, 2017	Z-2733-2017	—	terminated	The Reusable Oscor ATAR extension cables could separate from the connector during use.
Oct 5, 2016	Z-0813-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0802-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0815-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0819-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0798-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0801-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0797-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0812-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0791-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0794-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0806-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0805-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0804-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0807-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0799-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0810-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0809-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0792-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0816-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0796-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0790-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0793-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0817-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0800-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0814-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0795-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0818-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0803-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0811-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0808-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Jul 25, 2012	Z-0165-2013	—	terminated	Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
Jul 3, 2008	Z-0130-2009	—	terminated	Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
Jan 29, 2008	Z-2333-2008	—	terminated	The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
Sep 13, 2005	Z-0345-06	—	terminated	Sheath size is larger than dilator size causing insertion difficulties.