Oscor, Inc.
Oscor, Inc. holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2021, with 39 FDA device recalls on record.
Top product codes for Oscor, Inc.
FDA recalls by Oscor, Inc.
10 most recent of 39- Z-2678-2026 — Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- Z-2679-2026 — Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
- Z-2680-2026 — Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- Z-0646-2022 — Destino Twist 14F (also branded as Guidestar 14F)
- Z-1329-2021 — AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
- Z-0391-2019 — TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.
- Z-2733-2017 — ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
- Z-2340-2017 — ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
- Z-0792-2017 — OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
- Z-0813-2017 — MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Oscor, Inc.
- K210627 — Breezeway II
- K151951 — Destino Reach
- K143463 — IS4/DF4 Port Plug
- K140917 — INTRODUCER, MODEL ADELANTE MAGNUM
- K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH
- K130633 — INTRODUCER SETS, MODEL ADELANTE RADIAL
- K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
- K130104 — GUIDEWIRE, PURSUER SERIES
- K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES
- K120459 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
- K101497 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K092118 — ANGIOGRAPHIC CATHETER, MODEL ANGIOS
- K090114 — MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
- K081986 — SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
- K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS
- K072770 — TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
- K073100 — INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
- K070926 — ELECTRODE/EXTENSION CABLES, MODELS ATAR
- K041809 — PERMANENT PACING LEAD, MODEL PY2
- K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
- K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
- K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
- K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
- K020669 — PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
- K013339 — PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
- K003918 — OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
- K010787 — PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
- K831926 — IMPLANTABLE ENDOCARDIAL PACING LEADS
- K831768 — EXTERNAL PULSE GENERATOR FOR TEMP. STIM
- K831695 — TEMP. CARDIAC PACING WIRE TME 60/61/65
- K831751 — LEAD INTRODUCER SETS-EB-S8 & EB-S12
- K831804 — MULTIPOLAR TEMPORARY CARDIAC
- K831997 — IMPLANTABLE ENDOCARDIAL PACING LEADS
- K831767 — IMPLANTABLE CARDIAC PACING LEADS
- K823889 — MODEL JY PACEMAKER LEAD - VARIOUS
- K823893 — MODEL MZ PACEMAKER LEAD-VARIOUS
- K823895 — MODEL RF. D&RX..D PACEMAKER LEADS
- K823897 — MODEL SF. D&SX.D PACEMAKER LEADS
- K823898 — MODEL MF..D & MX..D PACEMAKER LEADS
- K830772 — TEMP. PACING LEAD, BIPOLAR #TH60, 90/110
- K830950 — VASCULAR PRODUCTS IMPLANTABLE PACING
- K823890 — MODEL ZY PACEMAKER LEAD-VARIOUS
- K823891 — MODEL KY PACEMAKER LEAD - VARIOUS
- K823446 — PRODUCTS IMPLANTABLE PACING LEAD,TINED
- K823448 — IMPLANTABLE PACING LEAD TINED #3390 &
- K791732 — IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC
- K782018 — LEADS, IMPLANTABLE CARDIAC PACEMAKERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.