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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 11 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Breezeway	AB063001	FDA UDI	Class II	Active
Occlutech® Steerable Guiding Sheath	51GS012	FDA UDI	Class II	Active
SafeSheath® II	SSC9	FDA UDI	Class II	Unknown
Atar D-Mdt2s-V	ATAR D-MDT2S-V	FDA UDI	Class II	Unknown
Destino Reach Steerable Guiding Sheath	DCR1007350	FDA UDI	Class II	Active
Adelante Sigma	ASG04010W	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007322GW	FDA UDI	Class II	Active
Adelante Sigma	ASG0402335	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 228 TC-2.5	FDA UDI	Class II	Active
Atar Mdtr	ATAR-MDTR	FDA UDI	Class II	Unknown
Angios Classic Angiographic Convenience Kit	ANG4-0442	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0052	FDA UDI	Class II	Active
Adelante Sigma	ETASG06010	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DCT1707125	FDA UDI	Class II	Active
Adelante Radial	ASR06025P	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0704509	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0857322	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0261	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0857350	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21101	FDA UDI	Class II	Active
Adelante Breezeway	AB101077	FDA UDI	Class II	Active
Adelante SafeSheath II	AS06023B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0067	FDA UDI	Class II	Active
Guidestar™ Steerable Guiding Sheath	D141102	FDA UDI	Class II	Active
Xi.v™	XI.V	FDA UDI	Class II	Unknown
Atar D-Mdt2	ATAR D-MDT2	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08530P	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP07023	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0961	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG080079180	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0498	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0804	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP11530P	FDA UDI	Class II	Active
Atar D-Mdtr	ATAR D-MDTR	FDA UDI	Class II	Unknown
Introducer set with hemostatic valve	DYNJINTROL8	FDA UDI	Class II	Unknown
Baylis Med Tech Passport Steerable Sheath	PSS0709009	FDA UDI	Class II	Active
Atar Mdts	ATAR-MDTS	FDA UDI	Class II	Unknown
Adelante Sigma	ASG04010	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS126750	FDA UDI	Class II	Active
Tb	020002	FDA UDI	Class II	Unknown
Breezeway II® Plus Delivery Sheath	BG060110045L	FDA UDI	Class II	Active
Occlutech Delivery Set III	98US010	FDA UDI	Class II	Active
Ligature Sleeve	LS26B20	FDA UDI	Class III	Active
Angios Classic Angiographic Convenience Kit	ANG4-0241	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC106750GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC857150GW	FDA UDI	Class II	Active
Adelante Radial	ASR04010P	FDA UDI	Class II	Active
Adelante Sigma	ASG09023W	FDA UDI	Class II	Active
Adelante Sigma	ASG0902335	FDA UDI	Class II	Active
Adelante Breezeway	AB101078	FDA UDI	Class II	Active

Related Companies

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Importers

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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.