313 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311, QTY 5 (b1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 0.5mm Tips, REF 20-0311R, QTY 5 (c1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.0mm Tips, REF 20-0321, QTY 5 (d1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth 1.5mm Tips, REF 20-0331, QTY 5 (e1) Insulated Irrigating Bayonet Forceps 6.25" (15.9cm) Smooth, 1.5mm Tips, REF 20-0331R, QTY 5 (f1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth Micro Tips, REF 20-0351, QTY 5 (g1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361, QTY 5 (h1) Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 0.5mm Tips, REF 20-0361G, QTY 5 (i1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 0.5mm Tips, REF 20-0361R, QTY 5 (j1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371, QTY 5 (k1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.0mm Tips, REF 20-0371R, QTY 5 (l1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381, QTY 5 (m1)Insulated Irrigating Bayonet Forceps 7-1/8" (181.0mm) 1.5mm Tips, REF 20-0381G, QTY 5 (n1) Insulated Irrigating Bayonet Forceps 7-1/8" (18.1cm) Smooth 1.5mm Tips, REF 20-0381R, QTY 5 (o1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411, QTY 5 (p1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 0.5mm Tips, REF 20-0411R, QTY 5 (q1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421, QTY 5 (r1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.0mm Tips, REF 20-0421R, QTY 5 (s1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431, QTY 5 (t1) Insulated Irrigating Bayonet Forceps 8.25" (309.6mm) 1.5mm Tips, REF 20-0431G, QTY 5 (u1) Insulated Irrigating Bayonet Forceps 8.25" (21.0cm) Smooth 1.5mm Tips, REF 20-0431R, QTY 5 (v1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481, QTY 5 (w1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.0mm Tips, REF 20-0481R, QTY 5 (x1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491, QTY 5 (y1) Insulated Irrigating Bayonet Forceps 10.5" (26.7cm) Smooth 1.5mm Tips, REF 20-0491R (z1) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 0.5mm Tips, REF 20-0571IMT, QTY 5 (a2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.0mm Tips, REF 20-0572IMT, QTY 5 (b2) Precision Non-Stick Insulated Irrigating Forceps 7" (17.8cm) 1.5mm Tips, REF 20-0573IMT, QTY 5 (c2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 0.5mm Tips, REF 20-0581IMT, QTY 5 (d2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.0mm Tips, REF 20-0582IMT, QTY 5 (e2) Precision Non-Stick Insulated Irrigating Forceps 8" (20.3cm) 1.5mm Tips, REF 20-0583IMT, QTY 5 (f2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 0.5mm Tips, REF 20-0591IMT, QTY 5 (g2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.0mm Tips, REF 20-0592IMT, QTY 5 (h2) Precision Non-Stick Insulated Irrigating Forceps 9" (22.9cm) 1.5mm Tips, REF 20-0593IMT (i2) Insulated Coaptation Forceps 4.5" (11.4cm) Smooth Micro Tips, Angled, REF 20-1010KI, QTY 10 (j2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, REF 20-1030K, QTY 10 (k2) Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040K, QTY 10 (l2) Insulated Iris Forceps 4.5" (11.4cm) Serrated 1.0mm Tips, Angled 45o, REF 20-1040KI, QTY 10 (m2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K, QTY 10 (n2) Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060K-28, QTY 10 (o2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Tips, REF 20-1060KI, QTY 10 (p2) Insulated Jewelers Forceps 4.5" (11.4cm) Smooth Micro Ti
FDA Enforcement
Class II
·Terminated·Olsen Medical·June 6, 2018
Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 Intended for use in coagulating tissue.
FDA Enforcement
Class II
·Terminated·Olsen Medical·June 6, 2018
Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8732, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8733, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8734, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8735, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8744, 270mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8745, 270mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8746, 270mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8747, 270mm x 270mm x 200mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Non-Perforated Bottom, REF 50-8748, 270mm x 270mm x 260mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Small 4 Latch, REF 50-8950, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Small 4 Latch, REF 50-8951, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Green Small 4 Latch, REF 50-8952, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Blue Small 4 Latch, REF 50-8953, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Red Small 4 Latch, REF 50-8954, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Black Small 4 Latch, REF 50-8955, 280mm x 276mm, QTY: 1, Symmetry Surgical, Inc., Medium Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8736, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8737, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Perforated Bottom, REF 50-8738, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8749, 440mm x 270mm x 100mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8750, 440mm x 270mm x 135mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Medium Non-Perforated Bottom, REF 50-8751, 440mm x 270mm x 150mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Grey Medium 4 Latch, REF 50-8956, 445mm x 279mm, QTY: 1, Symmetry Surgical, Inc., Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Lid Yellow Medium 4 Latch, REF 50-8957, 445mm x 279mm, QTY: 1,
FDA Enforcement
Class II
·Terminated·Symmetry Medical/SSI·February 5, 2014
Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF 75800, QTY 25 (e) Button Switchpen, w/ Extendable Blade Electrode, 2 mm Exposure, REF 75810, QTY 25 (f) Button Switchpen, w/ Extendable Needle Electrode, 2 mm Exposure, REF 75820, QTY 25 (g) Foot Controlled Handle, w / Standard Blade electrode, REF 95012, QTY 100 Designed to hold active electrodes.
FDA Enforcement
Class II
·Terminated·Olsen Medical·June 6, 2018
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
FDA Enforcement
Class II
·Ongoing·Lucid Diagnostics, Inc.·June 5, 2024
Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-2920K, QTY 10 (d) Insulated Bayonet Forceps 7.5" (19.1cm) 1.5mm Cathedral Tips, REF 20-2960HK, QTY 10
FDA Enforcement
Class II
·Terminated·Olsen Medical·June 6, 2018
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
FDA Enforcement
Class II
·Ongoing·International Life Sciences·March 18, 2026
TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 125o, REF 71675203, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL, 125o, REF 71675204, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL, 125o, REF 71675205, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL, 125o, REF 71675206, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 130o, REF 71675207, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 130o, REF 71675208, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 18 CM NAIL, 130o, REF 71675209, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 20 CM NAIL, 130o, REF 71675210, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 20 CM NAIL, 130o, REF 71675211, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 13MM X 20 CM NAIL, 130o, REF 71675212, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL, 125o, LEFT, REF 71675213, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 32 CM NAIL, 125o, LEFT, REF 71675219, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL, 125o, LEFT, REF 71675221, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 34 CM NAIL, 125o, RIGHT, REF 71675222, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 36 CM NAIL, LEFT, 125o, REF 71675223, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 38 CM NAIL, 125o, LEFT, REF 71675225, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL, 125o, LEFT, REF 71675227, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 40 CM NAIL, 125o, RIGHT, REF 71675228, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 28 CM NAIL, 125o, RIGHT, REF 71675238, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 32 CM NAIL, 125o, LEFT, REF 71675241, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL, 125o, LEFT, REF 71675243, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 34 CM NAIL, 125o, RIGHT, REF 71675244, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL, 125o, LEFT, REF 71675245, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 36 CM NAIL, 125o, RIGHT, REF 71675246, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL, 125o, LEFT, REF 71675247, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 38 CM NAIL, 125o, RIGHT, REF 71675248, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL, 125o, LEFT, REF 71675249, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 40 CM NAIL, 125o, RIGHT, REF 71675250, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 10MM X 26 CM NAIL, 130o, LEFT, REF 71675257, QTY (1), STERILE R, Smi
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·August 27, 2014
Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Designed to bring high frequency electrical power from the electrosurgical generator to the active.
FDA Enforcement
Class II
·Terminated·Olsen Medical·June 6, 2018
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
FDA Enforcement
Class II
·Ongoing·Lucid Diagnostics, Inc.·June 5, 2024
Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
FDA Enforcement
Class II
·Terminated·Medtronic Neurosurgery·February 21, 2018
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
FDA Enforcement
Class II
·Terminated·Ortho Organizers, Inc.·July 8, 2020
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
FDA Enforcement
Class II
·Terminated·Bard Peripheral Vascular Inc·October 27, 2021
Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
FDA Enforcement
Class II
·Terminated·Arcos, Inc·August 28, 2019
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 26, 2012
Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430.
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology Inc·December 29, 2021
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·June 20, 2018
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
FDA Enforcement
Class II
·Ongoing·Fresenius Kabi USA, LLC·August 6, 2025
PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·December 14, 2016
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·May 10, 2017