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 25 of 25

Device	Model / Reference	Registries	Class	Status
Delivery Sheath, Model Adelante Breezeway	K122958	FDA 510(k)	Class II	Active
Pacing Lead Bipolar Adapters And Extensions	K010787	FDA 510(k)	Class II	Active
Delivery Sheath, Model Adelante Breezeway	K101497	FDA 510(k)	Class II	Active
Steerable Guiding Sheath, Model Adelante Destino	K122960	FDA 510(k)	Class II	Active
External Pulse Generator For Temp. Stim	K831768	FDA 510(k)	Class II	Active
Multipolar Temporary Cardiac	K831804	FDA 510(k)	Class II	Active
Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, Rju	K040569	FDA 510(k)	Class III	Active
Implantable Endocardial Pacing Leads	K831926	FDA 510(k)	Class I	Active
Permanent Pacing Lead, Models Petite, Petite R, J, Rj, Petite B, Rb, Jb, Rjb	K020669	FDA 510(k)	Class III	Active
IS4/DF4 Port Plug	K143463	FDA 510(k)	Class II	Active
Vascular Products Implantable Pacing	K830950	FDA 510(k)	Class III	Active
Introducer Sets, Model Adelante Radial	K130633	FDA 510(k)	Class II	Active
Electrode/Extension Cables, Models Atar	K070926	FDA 510(k)	Class II	Active
Permanent Pacing Lead W/Polaris Coated Tips, Various Models	K013339	FDA 510(k)	Class III	Active
Modification To:introducer Sets, Model Adelante And Adelante-S	K090114	FDA 510(k)	Class II	Active
Guidewire, Pursuer Series	K130104	FDA 510(k)	Class II	Active
Model Mf..d & Mx..d Pacemaker Leads	K823898	FDA 510(k)	Class III	Active
Model Rf. D&Rx..d Pacemaker Leads	K823895	FDA 510(k)	Class III	Active
Occlusion Balloon Catheter, Model Venos	K081052	FDA 510(k)	Class II	Active
Implantable Pacing Lead Tined #3390 &	K823448	FDA 510(k)	Class III	Active
Oscor Permanent Pacing Lead Rz Model Series	K003918	FDA 510(k)	Class III	Active
Introducer Sets, Models Adelante And Adelante-S	K073100	FDA 510(k)	Class II	Active
Leads, Implantable Cardiac Pacemakers	K782018	FDA 510(k)	Class III	Active
Model Jy Pacemaker Lead - Various	K823889	FDA 510(k)	Class III	Active
Model Ky Pacemaker Lead - Various	K823891	FDA 510(k)	Class III	Active
Model Mz Pacemaker Lead-Various	K823893	FDA 510(k)	Class III	Active
Introducer, Model Adelante Magnum	K140917	FDA 510(k)	Class II	Active
Temporary Pacing Lead, Series Tbb, Model Helios (tm)	K072770	FDA 510(k)	Class II	Active
Temp. Cardiac Pacing Wire Tme 60/61/65	K831695	FDA 510(k)	Class II	Active
Implantable Endocardial Pacing Leads	K831997	FDA 510(k)	Class III	Active
Destino Reach	K151951	FDA 510(k)	Class II	Active
Lead Introducer Sets-Eb-S8 & Eb-S12	K831751	FDA 510(k)	Class II	Active
Angiographic Catheter, Model Angios	K092118	FDA 510(k)	Class II	Active
Model Sf. D&Sx.d Pacemaker Leads	K823897	FDA 510(k)	Class III	Active
Permanent Pacing Lead, Model Py2	K041809	FDA 510(k)	Class III	Active
Introducer Set, Model Adelante-S Series	K122084	FDA 510(k)	Class II	Active
Safesept Transseptal Trocar Guidewire	K081986	FDA 510(k)	Class II	Active
Temp. Pacing Lead, Bipolar #th60, 90/110	K830772	FDA 510(k)	Class II	Active
Permanent Pacing Leads, Models Physique Pb And Pjb	K024053	FDA 510(k)	Class III	Active
Steerable Guiding Sheath, Model Adelante Destino	K120459	FDA 510(k)	Class II	Active
Implantable Cardiac Pacing Leads	K831767	FDA 510(k)	Class III	Active
Products Implantable Pacing Lead, Tined	K823446	FDA 510(k)	Class III	Active
Destino Twist, Steerable Guiding Sheath	K140406	FDA 510(k)	Class II	Active
Breezeway II	K210627	FDA 510(k)	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.