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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 3 of 25

Device	Model / Reference	Registries	Class	Status
Destino Reach Steerable Guiding Sheath	DCR1207122GW	FDA UDI	Class II	Active
Bis/Blv-4402	BIS/BLV-4402	FDA UDI	Class II	Active
Adelante Sigma	ASG10023P	FDA UDI	Class II	Active
Atar D-A	ATAR D-A	FDA UDI	Class II	Active
IS4/DF4 Plug	667148-300	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP06023	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0258	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454992	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454995	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP851318	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0801	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter Kit	ANG3-0240	FDA UDI	Class II	Active
SafeSheath® II	667461-300	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP091318P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1707150	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09516B5	FDA UDI	Class II	Active
SafeSheath® II	SSL7	FDA UDI	Class II	Active
Tb	TBK05110USG	FDA UDI	Class II	Unknown
Adelante Radial	ASR0500718B5	FDA UDI	Class II	Active
Atar R1	ATAR-R1	FDA UDI	Class II	Unknown
Adelante Breezeway	AB081043	FDA UDI	Class II	Active
Xi.a™	XI.A	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0088	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0041	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1207550	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST06510007D2	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0496	FDA UDI	Class II	Active
Adelante S	ASU0913B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0240	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS400	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DS007	FDA UDI	Class II	Active
Regulus Introducer Set with Hemostatic Valve	SYM-IS-003	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1207522	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG105-0304	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0040	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0276	FDA UDI	Class II	Active
Adelante Sigma	ASG07010	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1407150	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1507125	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0503	FDA UDI	Class II	Active
Adelante Radial	ASR0600718B5	FDA UDI	Class II	Active
Adelante Radial	ASR04007B5	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP12	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP09030P	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG090079045L	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0240	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0856717	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0856530	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROPL10	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP06023B5	FDA UDI	Class II	Active

Related Companies

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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.