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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 17 of 25

Device	Model / Reference	Registries	Class	Status
Baylis Med Tech Passport Steerable Sheath	PSS0704509	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROS10	FDA UDI	Class II	Unknown
Introducer set with hemostatic valve	DYNJINTROS8	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG060079180	FDA UDI	Class II	Active
SafeSheath® Ultra	SU12	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0704517	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1204022	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0498	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC127150GW	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0659009	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0262	FDA UDI	Class II	Active
Is4/Df4 Plug	IS4/DF4 PLUG	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1405550	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3015	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0856717GW	FDA UDI	Class II	Active
SafeSheath® Ultra	SUL6	FDA UDI	Class II	Active
Adelante Breezeway	AB063009	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10023P	FDA UDI	Class II	Active
Tb	020022	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DC856150	FDA UDI	Class II	Active
Adelante Breezeway	AB081043GW	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0405	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09016P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0960	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DS011	FDA UDI	Class II	Active
Vv-Plug	667145-301	FDA UDI	Class III	Active
Adelante Breezeway	AB073001	FDA UDI	Class II	Active
Tb	020004	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG106-0105	FDA UDI	Class II	Active
Adelante Sigma	ASG10023W	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1505525	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS107122	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 224 TC	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0655509TD	FDA UDI	Class II	Active
Ligature Sleeve	LS17B20	FDA UDI	Class III	Active
Destino Twist Steerable Guiding Sheath	DST0655522	FDA UDI	Class II	Active
Adelante Sigma	ASG04023P	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP07045P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1607125	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0855517	FDA UDI	Class II	Active
Lead Adaptor	666162-301	FDA UDI	Class II	Unknown
SafeSheath® Ultra	SU6	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROR6	FDA UDI	Class II	Unknown
Adelante Breezeway	AB081211	FDA UDI	Class II	Active
Ligature Sleeve	LS-26	FDA UDI	Class III	Active
Xi.d-T™	XI.D-T	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0803	FDA UDI	Class II	Active
Adelante Radial	ASR0501018B5	FDA UDI	Class II	Active
Venos Occlusion Balloon Catheter	V068010	FDA UDI	Class II	Active
Tb	TBRHK05110SSG	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.