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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 2 of 25

Device	Model / Reference	Registries	Class	Status
Destino Twist Steerable Guiding Sheath	DCT1407125NM	FDA UDI	Class II	Active
Tb	020009	FDA UDI	Class II	Unknown
Destino Reach Steerable Guiding Sheath	DCR0857350GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856150GW	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0023	FDA UDI	Class II	Active
Lv-1 Plug	LV-1 PLUG	FDA UDI	Class II	Active
Ligature Sleeve	LS21B20	FDA UDI	Class III	Active
Destino Twist Steerable Guiding Sheath	DST1357125NM	FDA UDI	Class II	Active
VV-Plug	667145-750	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter Kit	ANG3-0239	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856122GW	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0267	FDA UDI	Class II	Active
Valve Bypass Tool	A11VBT03B25	FDA UDI	Class II	Active
SafeSheath® Ultra Lite	VI8	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0857722	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP6	FDA UDI	Class II	Unknown
Baylis Med Tech Passport Steerable Sheath	PSS0656509	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG110079180	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS126750GW	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1607150	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter Kit	ANG3-0042	FDA UDI	Class II	Active
2xbis/Bis-17	2XBIS/BIS-17	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0804	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3006	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 64 TC	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0497	FDA UDI	Class II	Active
Tb	TBRHK06110SSG	FDA UDI	Class II	Unknown
SafeSheath® II	SS8	FDA UDI	Class II	Active
Atar R X2	ATAR-R X2	FDA UDI	Class II	Unknown
Peel-away introducer set	DYNJINTROP85	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP07030P	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12023B5	FDA UDI	Class II	Active
Adelante Radial	ASR0502518B5	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1507125GW	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10016B5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC107122GW	FDA UDI	Class II	Active
Adelante Breezeway	AB081044GW	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP06010	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 228 TS	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS127117GW	FDA UDI	Class II	Active
Adelante Breezeway	AB081041	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP95	FDA UDI	Class II	Unknown
Adelante Radial	ASR05007P	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG080110045	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0263	FDA UDI	Class II	Active
Atar A	ATAR-A	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP08516B5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC857122	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0037	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG105-0010	FDA UDI	Class II	Active

Related Companies

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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.