Is this your brand? Sign in to claim ownership.

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 1 of 25

Device	Model / Reference	Registries	Class	Status
SafeSheath® II	SS11	FDA UDI	Class II	Active
Adelante Breezeway	AB101074	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0800	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3001	FDA UDI	Class II	Active
Tb	020013	FDA UDI	Class II	Unknown
B/Is-15 Ss2	B/IS-15 SS2	FDA UDI	Class II	Active
Adelante Magnum	ASM016020	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856722GW	FDA UDI	Class II	Active
Valve Bypass Tool	A06VBT03B25	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST12010022	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG080079045L	FDA UDI	Class II	Active
Helios	H05RH110U	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0503	FDA UDI	Class II	Active
Helios	H05110U	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DS012	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL12	FDA UDI	Class II	Unknown
SafeSheath® Ultra	SUL9	FDA UDI	Class II	Active
Adelante Breezeway	AB101218	FDA UDI	Class II	Active
C/Is-10	C/IS-10	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0961	FDA UDI	Class II	Active
Xi.d-V™	XI.D-V	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST1705525	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC126750GW	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1207550	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 60 S	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP06030P	FDA UDI	Class II	Active
Xi.d-Mdt™	XI.D-MDT	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST0705517	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0704509	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0656509TD	FDA UDI	Class II	Active
Adelante Sigma	ASGAT11016	FDA UDI	Class II	Active
Adelante Sigma	ASG12023P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0706530	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21103	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0277	FDA UDI	Class II	Active
Adelante Breezeway	AB073003	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG505-0203	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007322	FDA UDI	Class II	Active
Adelante Radial	ASR0400718B5	FDA UDI	Class II	Active
Venos Occlusion Balloon Catheter	V068015	FDA UDI	Class II	Unknown
Destino Reach Steerable Guiding Sheath	DCR0857322GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856122	FDA UDI	Class II	Active
Atar V	ATAR-V	FDA UDI	Class II	Unknown
Venos Occlusion Balloon Catheter	V0510015	FDA UDI	Class II	Unknown
Adelante SafeSheath II	AS95013B5	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROR4	FDA UDI	Class II	Unknown
Tb	020005	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG120079045	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0042	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL10	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.