Is this your brand? Sign in to claim ownership.

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 20 of 25

Device	Model / Reference	Registries	Class	Status
Venos Occlusion Balloon Catheter	V0510010	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DCT1207150	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007317	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP11023B5	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007722GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC107117GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21100	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC126717	FDA UDI	Class II	Active
Valve Bypass Tool	A125VBT03B25	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0654522	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG506-0306	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS126722	FDA UDI	Class II	Active
Adelante Breezeway	AB081047GW	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3000	FDA UDI	Class II	Active
SafeSheath® II	SS85	FDA UDI	Class II	Active
Tb	TBRHK04110SSG	FDA UDI	Class II	Unknown
Ligature Sleeve	LS-15	FDA UDI	Class III	Active
Peel-away introducer set	DYNJINTROP105	FDA UDI	Class II	Unknown
Adelante Radial	ASR0402518B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0290	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1207150GW	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG090110045	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0705522	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08016P	FDA UDI	Class II	Active
Adelante SafeSheath II	AS12013B5	FDA UDI	Class II	Active
SafeSheath® Ultra	SUL7	FDA UDI	Class II	Active
Adelante Sigma	ASG06023	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG140079045	FDA UDI	Class II	Active
iLINK-BIS-10	iLINK-BIS-10	FDA UDI	Class II	Active
Adelante SafeSheath II	AS10513B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG505-0204	FDA UDI	Class II	Active
Atar D-T	ATAR D-T	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0240	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROS12	FDA UDI	Class II	Unknown
Lead Adaptor Bipolar/Unipolar	BLV/BIS-40	FDA UDI	Class II	Active
Helios	H05110S	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0855517	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DL009	FDA UDI	Class II	Active
Adelante Radial	ASR04025B5	FDA UDI	Class II	Active
Adelante Radial	ASR06025NPB5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856750	FDA UDI	Class II	Active
Valve Bypass Tool	A09VBT05B25	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP131318P	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP7	FDA UDI	Class II	Unknown
Introducer set with hemostatic valve	DYNJINTROS9	FDA UDI	Class II	Unknown
Venos Occlusion Balloon Catheter	V0612015	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0270	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC857117	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG070079180L	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1387139	FDA UDI	Class II	Active

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.