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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 23 of 25

Device	Model / Reference	Registries	Class	Status
Angios Classic Angiographic Catheter	ANG5-0960	FDA UDI	Class II	Active
Adelante Sigma	ASG05023P	FDA UDI	Class II	Active
Adelante Breezeway	AB081040	FDA UDI	Class II	Active
Atar Mdt3	ATAR-MDT3	FDA UDI	Class II	Unknown
Valve Bypass Tool	A06VBT05B25	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0655509	FDA UDI	Class II	Active
Adelante Radial	ASR04007NPB5	FDA UDI	Class II	Active
Atar D-Mdt3	ATAR D-MDT3	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP06023P	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856150GW	FDA UDI	Class II	Active
Adelante Sigma	ASG10023	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12016B5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0500	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0963	FDA UDI	Class II	Active
Adelante SafeSheath II	AS12513B5	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 66 TC	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0279	FDA UDI	Class II	Active
Occlutech® Steerable Guiding Sheath	51GS014	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0798	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0280	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3001	FDA UDI	Class II	Active
SafeSheath® II	SSL6	FDA UDI	Class II	Active
Valve Bypass Tool	A09VBT03B25	FDA UDI	Class II	Active
Valve Bypass Tool	A08VBT03B25	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0063	FDA UDI	Class II	Active
Ligature Sleeve	LS18B20	FDA UDI	Class III	Active
Senovo Bi-Flex Steerable Guiding Sheath	454953	FDA UDI	Class II	Active
SafeSheath® Ultra	SUL10	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG506-0305	FDA UDI	Class II	Active
Adelante Sigma	ASG0702335	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG090110045L	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0504	FDA UDI	Class II	Active
Valve Bypass Tool	A105VBT03B25	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0249	FDA UDI	Class II	Active
CORMOS® Medical Steerable Guiding Sheath	3032EFS.2.14	FDA UDI	Class II	Active
Valve Bypass Tool	A75VBT03B25	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0088	FDA UDI	Class II	Active
Tb	020021	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG100079045	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0796	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0655507D2	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG105-0303	FDA UDI	Class II	Active
SafeSheath® Ultra	SU125	FDA UDI	Class II	Active
SafeSheath® II	SS10	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0798	FDA UDI	Class II	Active
Xi.d-V™	XI.D-V	FDA UDI	Class II	Active
Adelante Sigma	ASG06023W	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP04010	FDA UDI	Class II	Active
SafeSheath® II	SS7	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12516B5	FDA UDI	Class II	Active

Related Companies

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Importers

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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.