68 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
FDA Enforcement
Class II
·Terminated·Custom Assemblies Inc·August 30, 2017
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
FDA Enforcement
Class II
·Terminated·Owens & Minor Distribution, Inc.·December 28, 2016
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·January 10, 2018
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·December 28, 2022
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
FDA Enforcement
Class II
·Ongoing·UNIMAX MEDICAL SYSTEMS INC·September 25, 2024
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
FDA Enforcement
Class II
·Terminated·Progressive Medical Inc·November 21, 2012
VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·October 30, 2013
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·November 4, 2015
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
FDA Enforcement
Class II
·Terminated·Smiths Medical Asd Inc·June 17, 2015
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·December 7, 2016
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Enforcement
Class II
·Terminated·Medical Action Industries Inc·July 9, 2014
(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx; (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·November 13, 2019