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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 12 of 25

Device	Model / Reference	Registries	Class	Status
Destino Twist Steerable Guiding Sheath	DST0706517	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS1209030	FDA UDI	Class II	Active
Atar-Mdt2s-A	ATAR-MDT2S-A	FDA UDI	Class II	Unknown
Pace 203h	PACE 203H LOANER	FDA UDI	Class II	Active
Tb	020018	FDA UDI	Class II	Unknown
Adelante Radial	ASR0401018B5	FDA UDI	Class II	Active
SafeSheath® II	SS12	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG080079180L	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0655517	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC107150	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP07530P	FDA UDI	Class II	Active
SafeSheath® Ultra	SUL8	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1407150GW	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0856717	FDA UDI	Class II	Active
Adelante Breezeway	AB081210	FDA UDI	Class II	Active
Adelante Magnum	ASM018020	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0286	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DS006	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0243	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	D0M122550	FDA UDI	Class II	Unknown
Adelante Radial	ASR05010NPB5	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG140079045L	FDA UDI	Class II	Active
Adelante Radial	ASR05025P	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3000	FDA UDI	Class II	Active
Lead Adaptor	664402-302	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG506-0112	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP0716GW2-BX5	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS127117	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS127150GW	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG100079045L	FDA UDI	Class II	Active
Adelante Radial	ASR06010P	FDA UDI	Class II	Active
Adelante Sigma	ASG08023W	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS107150GW	FDA UDI	Class II	Active
M/Is-10	M/IS-10	FDA UDI	Class II	Active
Adelante S	ASU0513B5	FDA UDI	Class II	Active
SafeSheath® II	667475-300	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0061	FDA UDI	Class II	Active
Adelante Sigma	ASG12023	FDA UDI	Class II	Active
Atar D-Mdt	ATAR D-MDT	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG105-0404	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1407125	FDA UDI	Class II	Active
Adelante Sigma	ASG06010P	FDA UDI	Class II	Active
LV-1 Plug	667147-301	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1207122	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0250	FDA UDI	Class II	Active
Valve Bypass Tool	A85VBT03B25	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROR5	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0958	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG105-0110	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1387139	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.