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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. AVL: The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·February 24, 2016

    Recreo Hair Growth Laser Comb

    FDA Enforcement
    Class II ·Ongoing·OMM Imports, Inc. dba Zero Gravity·March 22, 2023

    Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)

    FDA Enforcement
    Class II ·Terminated·Orthofix, Inc·June 13, 2018

    Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024

    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti

    FDA Enforcement
    Class II ·Ongoing·BALT USA, LLC·February 14, 2024

    Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 15, 2014

    PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J +6MM; and

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.

    FDA Enforcement
    Class II ·Terminated·Orthopedic Alliance LLC·June 5, 2013

    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J +6 mm TB; Right Size 1-2 CD +0 mm TB; Right Size CD +6 mm TB; Right Size EF +0 mm TB; Right Size EF +6 mm TB; Right Size GH +0 mm TB; Right Size GH +6 mm TB; Right Size J +0 mm TB; and Right Size J +6 mm TB.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·July 5, 2023

    AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118

    FDA Enforcement
    Class II ·Ongoing·Tornier, Inc·July 5, 2023

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016

    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·March 20, 2013

    Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

    FDA Enforcement
    Class II ·Ongoing·BALT USA, LLC·June 25, 2025

    NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1051-010 PACKAGED END CAP, 8.5/ 10.7MM, +10MM CPA2-015 PA1051-015 PACKAGED END CAP, 8.5/ 10.7MM, +15MM CPA2-020 PA1051-020 PACKAGED END CAP, 8.5/ 10.7MM, +20MM CPA3-000 PA1052-000 PACKAGED END CAP, 12.5MM , +0MM CPA3-005 PA1052-005 PACKAGED END CAP, 12.5MM , +5MM CPA3-010 PA1052-010 PACKAGED END CAP, 12.5MM , +10MM CPA3-015 PA1052-015 PACKAGED END CAP, 12.5MM , +15MM CPA3-020 PA1052-020 PACKAGED END CAP, 12.5MM , +20MM HEC1-000 PA0709-000 END CAP, 0MM HUMERAL NAIL HEC2-000 PA0709-002 END CAP, 2MM HUMERAL NAIL HEC3-000 PA0709-005 END CAP, 5MM HUMERAL NAIL HEC4-000 PA0709-010 END CAP, 10MM HUMERAL NAIL HEC5-000 PA0709-015 END CAP, 15MM HUMERAL NAIL LSB3-020 PP1699-020 Locking Screw, 3.5mm x 2 0mm LSB3-025 PP1699-025 Locking Screw, 3.5mm x 2 5mm LSB3-030 PP1699-030 Locking Screw, 3.5mm x 3 0mm LSB3-035 PP1699-035 Locking Screw, 3.5mm x 3 5mm LSB3-040 PP1699-040 Locking Screw, 3.5mm x 4 0mm LSB3-045 PP1699-045 Locking Screw, 3.5mm x 4 5mm LSB3-050 PP1699-050 Locking Screw, 3.5mm x 5 0mm LSB3-055 PP1699-055 Locking Screw, 3.5mm x 5 5mm LSB3-060 PP1699-060 Locking Screw, 3.5mm x 6 0mm LSB3-200-S PA1220-020 3.5mm x 20mm Screw, Peg LSB3-250-S PA1220-025 3.5mm x 25mm Screw, Peg LSB3-300-S PA1220-030 3.5mm x 30mm Screw, Peg LSB3-350-S PA1220-035 3.5mm x 35mm Screw, Peg LSB3-400-S PA1220-040 3.5mm x 40mm Screw, Peg LSB3-450-S PA1220-045 3.5mm x 45mm Screw, Peg LSB3-500-S PA1220-050 3.5mm x 50mm Screw, Peg LSB3-550-S PA1220-055 3.5mm x 55mm Screw, Peg LSB3-600-S PA1220-060 3.5mm x 60mm Screw, Peg LSB4-020 PP1425-020 Locking Screw, 4.0mm x 20mm LSB4-025 PP1425-025 Locking Screw, 4.0mm x 25mm LSB4-030 PP1425-030 Locking Screw, 4.0mm x 30mm LSB4-035 PP1425-035 Locking Screw, 4.0mm x 35mm LSB4-040 PP1425-040 Locking Screw, 4.0mm x 40mm LSB4-045 PP1425-045 Locking Screw, 4.0mm x 45mm LSB4-050 PP1425-050 Locking Screw, 4.0mm x 50mm LSB4-055 PP1425-055 Locking Screw, 4.0mm x 55mm LSB4-060 PP1425-060 Locking Screw, 4.0mm x 60mm LSB5-020 PP1426-020 Locking Screw, 5.0mm x 20mm LSB5-025 PP1426-025 Locking Screw, 5.0mm x 25mm LSB5-030 PP1426-030 Locking Screw, 5.0mm x 30mm LSB5-035 PP1426-035 Locking Screw, 5.0mm x 35mm LSB5-040 PP1426-040 Locking Screw, 5.0mm x 40mm LSB5-045 PP1426-045 Locking Screw, 5.0mm x 45mm LSB5-050 PP1426-050 Locking Screw, 5.0mm x 50mm LSB5-055 PP1426-055 Locking Screw, 5.0mm x 55mm LSB5-060 PP1426-060 Locking Screw, 5.0mm x 60mm LSB5-065 PP1426-065 Locking Screw, 5.0mm x 65mm LSB5-070 PP1426-070 Locking Screw, 5.0mm x 70mm LSB5-075 PP1426-075 Locking Screw, 5.0mm x 75mm LSC4-020 PP1794-020 Locking Screw, 4.0mm x 2 0mm LSC4-025 PP1794-025 Locking Screw, 4.0mm x 2 5mm LSC4-030 PP1794-030 Locking Screw, 4.0mm x 3 0mm LSC4-035 PP1794-035 Locking Screw, 4.0mm x 3 5mm LSC4-040 PP1794-040 Locking Screw, 4.0mm x 4 0mm LSC4-045 PP1794-045 Locking Screw, 4.0mm x 4 5mm LSC4-050 PP1794-050 Locking Screw, 4.0mm x 5 0mm LSC4-055 PP1794-055 Locking Screw, 4.0mm x 5 5mm LSC4-060 PP1794-060 Locking Screw, 4.0mm x 6 0mm LSC4-200-S PA1221-020 4.0mm x 20mm Screw, Peg LSC4-250-S PA1221-025 4.0mm x 25mm Screw, Peg LSC4-300-S PA1221-030 4.0mm x 30mm Screw, Peg LSC4-350-S PA1221-035 4.0mm x 35mm Screw, Peg LSC4-400-S PA1221-040 4.0mm x 40mm Screw, Peg LSC4-450-S PA1221-045 4.0mm x 45mm Screw, Peg LSC4-500-S PA1221-050 4.0mm x 50mm Screw, Peg LSC4-550-S PA1221-055 4.0mm x 55mm Screw, Peg LSC4-600-S PA1221-060 4.0mm x 60mm Screw, Peg LSC5-020 PP1742-020 Locking Screw, 5.0mm x 2 0mm LSC5-025 PP1742-025 Locking Screw, 5.0mm x 2 5mm LSC5-030 PP1742-030 Locking Screw, 5.0mm x 3 0mm LSC5-035 PP1742-035 Locking Screw, 5.0mm x 3 5mm LSC5-040 PP1742-040 Locking Screw, 5.0mm x 4 0mm LSC5-045 P

    FDA Enforcement
    Class II ·Ongoing·NuVasive Specialized Orthopedics, Inc.·December 8, 2021

    Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-2.5 MM GLOBAL, m) 7151015ES: 15CM, 1-1.5 MM GLOBAL, n) 7151520ES: 15CM, 1.5- 2 MM GLOBAL, o) 7152025ES: 15CM, 2-2.5 MM GLOBAL, p) 7451015ES: 45CM, 1-1.5 MM GLOBAL, q) 7451520ES: 45CM, 1.5-2 MM GLOBAL, r) 7452025ES: 45CM, 2-2.5 MM GLOBAL

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·April 10, 2024