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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 14 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Peel-Away Introducer Set	AP06045P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1707150GW	FDA UDI	Class II	Active
Occlutech Delivery Set III	98US007	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS857122	FDA UDI	Class II	Active
Adelante Breezeway	AB083010	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0655517	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1505550	FDA UDI	Class II	Active
Adelante SafeSheath II	AS11013B5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS126717GW	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL9	FDA UDI	Class II	Unknown
Temporary Myocardial Heartwire	TME 64 TS	FDA UDI	Class II	Active
Tb	TBRHK04110USG	FDA UDI	Class II	Unknown
Adelante S	ASU7513B5	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09023B5	FDA UDI	Class II	Active
SafeSheath® II	667464-300	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0237	FDA UDI	Class II	Unknown
Tb	020023	FDA UDI	Class II	Unknown
Adelante Breezeway	AB063006	FDA UDI	Class II	Active
C/Is-10 Ss2	C/IS-10 SS2	FDA UDI	Class II	Active
SafeSheath® II	667463-300	FDA UDI	Class II	Active
Atar V2	ATAR-V2	FDA UDI	Class II	Unknown
Tb	TBVK04110USG	FDA UDI	Class II	Unknown
Venos Occlusion Balloon Catheter	V0610010	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09023P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0797	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0805	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0705517	FDA UDI	Class II	Active
Atar D-T2	ATAR D-T2	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP07516P	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10516B5	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0857317	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROPL9	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DS107150	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROS11	FDA UDI	Class II	Unknown
M/Is-40	M/IS-40	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP09016B5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC106722	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0043	FDA UDI	Class II	Active
Blv/Bis-10	BLV/BIS-10	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL5	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0089	FDA UDI	Class II	Active
Occlutech Delivery Set III	98US008	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1605525	FDA UDI	Class II	Active
Tb	020014	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP10016P	FDA UDI	Class II	Active
Adelante Breezeway	AB101076	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP06016P	FDA UDI	Class II	Active
LV-1 Plug	667147-300	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0962	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0041	FDA UDI	Class II	Active

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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.