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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 16 of 25

Device	Model / Reference	Registries	Class	Status
Destino Steerable Guiding Sheath	DC857122GW	FDA UDI	Class II	Active
Adelante Breezeway	AB063004	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856150	FDA UDI	Class II	Active
Adelante S	ASU1113B5	FDA UDI	Class II	Active
Atar D-R X2	ATAR D-R X2	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DC126722	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC106722GW	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3025	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0050	FDA UDI	Class II	Active
Tb	020020	FDA UDI	Class II	Unknown
Peel-away introducer set	DYNJINTROP10	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST1209030	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 61 C	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0086	FDA UDI	Class II	Active
Adelante Sigma	ASG07023	FDA UDI	Class II	Active
Adelante Radial	ASR05010B5	FDA UDI	Class II	Active
Adelante SafeSheath II	AS09013B5	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG080079045	FDA UDI	Class II	Active
Tb	020016	FDA UDI	Class II	Unknown
Arrive™ Braided Transseptal Sheath	990061-120	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS107122GW	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS500	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL7	FDA UDI	Class II	Unknown
Introducer Kit for Impella®	0052-3025	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG120079045L	FDA UDI	Class II	Active
SafeSheath® II	SSCL9	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007350GW	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0260	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0962	FDA UDI	Class II	Active
5391	5391	FDA UDI	Class II	Unknown
Atar R T4p	ATAR-R T4P	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST0857350	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 225 TC	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1605550	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG060110045	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21102	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0259	FDA UDI	Class II	Active
Ligature Sleeve	LS-17	FDA UDI	Class III	Active
Breezeway II® Plus Delivery Sheath	BG140079045L08	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08023B5	FDA UDI	Class II	Active
Tb	TBJK04110USG	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DC127122GW	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1407125GW	FDA UDI	Class II	Active
Xi.d-Mdt™	XI.D-MDT	FDA UDI	Class II	Unknown
Lead Adaptor	BISX2-52	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROPL11	FDA UDI	Class II	Unknown
Introducer Kit for Impella®	0052-3015	FDA UDI	Class II	Active
Adelante Sigma	ASG08010	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP07023B5	FDA UDI	Class II	Active
Venos Occlusion Balloon Catheter	V058015	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.