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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 5 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Peel-Away Introducer Set	AP10516	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856750	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC106750	FDA UDI	Class II	Active
Xi.d-A™	XI.D-A	FDA UDI	Class II	Active
Atar D-R	ATAR D-R	FDA UDI	Class II	Active
Ligature Sleeve	LS-24	FDA UDI	Class III	Active
Angios Classic Angiographic Catheter	ANG505-0010	FDA UDI	Class II	Active
Adelante Radial	ASR04007P	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL4	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DS856717GW	FDA UDI	Class II	Active
Adelante Radial	ASR04010NPB5	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG070110045L	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0704517	FDA UDI	Class II	Active
Tb	TBK04110USG	FDA UDI	Class II	Unknown
SafeSheath® Ultra	SU10	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0205	FDA UDI	Class II	Active
Tb	TBRHK06110USG	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST0859017	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0654517	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0238	FDA UDI	Class II	Unknown
Temporary Myocardial Heartwire	TME 61 TC	FDA UDI	Class II	Active
SafeSheath® II Worley Right-sided Access Introducer	SSR9	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0077	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS300	FDA UDI	Class II	Active
Adelante Radial	ASR06007P	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12016P	FDA UDI	Class II	Active
SafeSheath® II	667460-300	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	21104	FDA UDI	Class II	Active
Adelante Sigma	ASG09010P	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007317GW	FDA UDI	Class II	Active
Helios	HRHCK05110U	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856717GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC857117GW	FDA UDI	Class II	Active
Valve Bypass Tool	A75VBT05B25	FDA UDI	Class II	Active
Xi.r™	XI.R	FDA UDI	Class II	Unknown
Pace 101h	PACE 101H	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0659009	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0656522	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG080110045L	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0062	FDA UDI	Class II	Active
Lead Adaptor	666161-301	FDA UDI	Class II	Unknown
Destino Steerable Guiding Sheath	DC127117GW	FDA UDI	Class II	Active
Lead Adaptor	BIS/BIS-17	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0859022	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3014	FDA UDI	Class II	Active
Occlutech Delivery Set III	98US009	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0857322	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROL6	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0058	FDA UDI	Class II	Active
SafeSheath® Ultra Lite	VI85	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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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.