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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 10 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Peel-Away Introducer Set	AP11030P	FDA UDI	Class II	Active
Atar Rl	ATAR-RL	FDA UDI	Class II	Unknown
Adelante Breezeway	AB081041GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC126750	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0706509	FDA UDI	Class II	Active
Valve Bypass Tool	A07VBT03B25	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0080	FDA UDI	Class II	Active
SafeSheath® Ultra	SU105	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0707517	FDA UDI	Class II	Active
Adelante Sigma	ASG07023P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0060	FDA UDI	Class II	Active
Adelante SafeSheath II	AS07013B5	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454955	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0799	FDA UDI	Class II	Active
SafeSheath® II	SSL8	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 227 TS	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP115	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG110079045	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS30S0	FDA UDI	Class II	Active
Ligature Sleeve	LS15B20	FDA UDI	Class III	Active
Occlutech Delivery Set III	98DL008	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS127122	FDA UDI	Class II	Active
Tb	TBK04110SSG	FDA UDI	Class II	Unknown
Adelante Sigma	ASG05023W	FDA UDI	Class II	Active
Atar D-Mdt2s-A	ATAR D-MDT2S-A	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0502	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP151318P	FDA UDI	Class II	Active
Bis/Blv-13	BIS/BLV-13	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0261	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP111318P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0502	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0090	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0655517	FDA UDI	Class II	Active
Ligature Sleeve	664760-302	FDA UDI	Class III	Active
Adelante Breezeway	AB073000	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0044	FDA UDI	Class II	Active
Adelante Sigma	ASG0502335	FDA UDI	Class II	Active
Adelante Radial	ASR06007B5	FDA UDI	Class II	Active
Guidewire with PTFE coating	21115	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0802	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP08516P	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP04023	FDA UDI	Class II	Active
Adelante Sigma	ASG05023	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST0855522	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0855522	FDA UDI	Class II	Active
Adelante Sigma	ASG09010W	FDA UDI	Class II	Active
Introducer Kit for Impella®	0052-3006	FDA UDI	Class II	Active
Adelante Radial	ASR05025NPB5	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR0856750	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0011	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.