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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 8 of 25

Device	Model / Reference	Registries	Class	Status
Angios Classic Angiographic Catheter	ANG1-0959	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0290	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP162025P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0259	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0268	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0071	FDA UDI	Class II	Active
Adelante Breezeway	AB101072	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS106750GW	FDA UDI	Class II	Active
VV-Plug	667145-751	FDA UDI	Class II	Active
Adelante Magnum	ASM018030	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1207139	FDA UDI	Class II	Active
Arrive™ Braided Transseptal Sheath	990061-070	FDA UDI	Class II	Active
Helios	HK05110U	FDA UDI	Class II	Active
Adelante Sigma	ASG0801035	FDA UDI	Class II	Active
Mc01b20	MC01B20	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP07016B5	FDA UDI	Class II	Active
B/Is-15	B/IS-15	FDA UDI	Class II	Unknown
Ligature Sleeve	664760-303	FDA UDI	Class III	Active
Temporary Myocardial Heartwire	TME 220 VC	FDA UDI	Class II	Active
Adelante S	ASU0613B5	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454996	FDA UDI	Class II	Active
Adelante Breezeway	AB063000	FDA UDI	Class II	Active
Xi.d-A™	XI.D-A	FDA UDI	Class II	Unknown
Adelante Sigma Plus	ASGP08023	FDA UDI	Class II	Active
Lead Adaptor	664402-301	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG5-0062	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP07016P	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10016	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 66 TS	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0258	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROPL8	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DS856722	FDA UDI	Class II	Active
Adelante SafeSheath II	AS10013B5	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0654509	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454993	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10023B5	FDA UDI	Class II	Active
Adelante Radial	ASR0601018B5	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007717GW	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 65 C	FDA UDI	Class II	Active
Adelante Breezeway	AB083007	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08023P	FDA UDI	Class II	Active
Arrive™ Braided Transseptal Sheath	990079-070	FDA UDI	Class II	Active
Atar Mdt2	ATAR-MDT2	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DC107122	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0040	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0856522	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS50S0	FDA UDI	Class II	Active
Adelante S	ASUL0923B5	FDA UDI	Class II	Active
Xi D-T™	XI D-T	FDA UDI	Class II	Unknown
Atar R	ATAR-R	FDA UDI	Class II	Unknown

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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.