Is this your brand? Sign in to claim ownership.

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 9 of 25

Device	Model / Reference	Registries	Class	Status
Adelante Sigma	ASG07010P	FDA UDI	Class II	Active
SafeSheath® II	SSL11	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP161318P	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0501	FDA UDI	Class II	Active
Adelante SafeSheath II	AS85013B5	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1207550	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0068	FDA UDI	Class II	Active
Tb	TBK06110USG	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST1405525	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DL007	FDA UDI	Class II	Active
Destino Twist HTS Steerable Guiding Sheath	DSTS1205520	FDA UDI	Class II	Unknown
Adelante Breezeway	AB081047	FDA UDI	Class II	Active
Adelante Breezeway	AB1004045	FDA UDI	Class II	Active
Lead Adaptor	666162-302	FDA UDI	Class II	Active
Adelante Sigma	ASG04023W	FDA UDI	Class II	Active
Xi.d-T™	XI.D-T	FDA UDI	Class II	Unknown
Destino Twist Steerable Guiding Sheath	DST0856722	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1207522GW	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0705509TD	FDA UDI	Class II	Active
Introducer set with hemostatic valve	DYNJINTROS5	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG1-0499	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter Kit	ANG3-0241	FDA UDI	Class II	Active
Adelante SafeSheath II	AS08023B5	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP07010	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG505-0009	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1207122	FDA UDI	Class II	Active
Lead Adaptor	B/IS-15	FDA UDI	Class II	Active
Adelante Sigma	ASG09010	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS107117GW	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0655509	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856117GW	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1204522	FDA UDI	Class II	Active
Adelante Sigma	ASG0401035	FDA UDI	Class II	Active
Adelante Radial	ASR06007NPB5	FDA UDI	Class II	Active
Atar D-R X2l	ATAR D-R X2L	FDA UDI	Class II	Unknown
SafeSheath® II	667470-300	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09516P	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 60 C	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0061	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0253	FDA UDI	Class II	Active
Adelante Breezeway	AB083001	FDA UDI	Class II	Active
Atar At	ATAR-AT	FDA UDI	Class II	Unknown
Adelante Peel-Away Introducer Set	AP12516P	FDA UDI	Class II	Active
Atar R T2p	ATAR-R T2P	FDA UDI	Class II	Unknown
Adelante Breezeway	AB081045	FDA UDI	Class II	Active
Adelante SafeSheath II	AS09023B5	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0242	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG140079045L10	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC106717	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROPL7	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.