33 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00
FDA Enforcement
Class II
·Ongoing·Mindray DS USA, Inc. dba Mindray North America·September 11, 2024
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L CAN, VLV EVOLUTPRO-26 PRO COMM 29L OUS SA; d. EVOLUTPRO-26-US, Labeled as: VLV EVOLUTPRO-26-US BLUE COMM US, VLV EVOLUTPRO-26-US PRO BLNK US; e. EVOLUTPRO-29, Labeled as: VLV EVOLUTPRO-29 PRO COMM 29L OUS, VLV EVOLUTPRO-29 BLUE 29L COMM OUS, VLV EVOLUTPRO-29 BLUE 6L COMM OUS, VLV EVOLUTPRO-29 PRO COMM 29L AUS, VLV EVOLUTPRO-29 BLUE COMM JPN, VLV EVOLUTPRO-29 PRO COMM 29L CAN, VLV EVOLUTPRO-29 PRO COMM 29L OUS SA; f. EVOLUTPRO-29-US, Labeled as: VLV EVOLUTPRO-29-US BLUE COMM US, VLV EVOLUTPRO-29-US PRO BLNK US g. , Labeled as:
FDA Enforcement
Class II
·Terminated·Medtronic Heart Valves Division·December 16, 2020
Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM 42540000041 PSN ALL POLY PAT PLY 41MM 42511000510 PSN ASF CR 10MM PLY L 3-1 42511000410 PSN ASF CR 10MM PLY L 3-9 42511000610 PSN ASF CR 10MM PLY L 7-1 42521000510 PSN ASF CR 10MM PLY R 3-1 42521000410 PSN ASF CR 10MM PLY R 3-9 42521000610 PSN ASF CR 10MM PLY R 7-1 42511000511 PSN ASF CR 11MM PLY L 3-1 42511000411 PSN ASF CR 11MM PLY L 3-9 42511000611 PSN ASF CR 11MM PLY L 7-1 42521000511 PSN ASF CR 11MM PLY R 3-1 42521000411 PSN ASF CR 11MM PLY R 3-9 42521000611 PSN ASF CR 11MM PLY R 7-1 42511000512 PSN ASF CR 12MM PLY L 3-1 42511000412 PSN ASF CR 12MM PLY L 3-9 42511000612 PSN ASF CR 12MM PLY L 7-1 42521000512 PSN ASF CR 12MM PLY R 3-1 42521000412 PSN ASF CR 12MM PLY R 3-9 42521000612 PSN ASF CR 12MM PLY R 7-1 42511000513 PSN ASF CR 13MM PLY L 3-1 42511000413 PSN ASF CR 13MM PLY L 3-9 42511000613 PSN ASF CR 13MM PLY L 7-1 42521000513 PSN ASF CR 13MM PLY R 3-1 42521000413 PSN ASF CR 13MM PLY R 3-9 42521000613 PSN ASF CR 13MM PLY R 7-1 42511000514 PSN ASF CR 14MM PLY L 3-1 42511000414 PSN ASF CR 14MM PLY L 3-9 42511000614 PSN ASF CR 14MM PLY L 7-1 42521000514 PSN ASF CR 14MM PLY R 3-1 42521000414 PSN ASF CR 14MM PLY R 3-9 42521000614 PSN ASF CR 14MM PLY R 7-1 42511000516 PSN ASF CR 16MM PLY L 3-1 42511000416 PSN ASF CR 16MM PLY L 3-9 42511000616 PSN ASF CR 16MM PLY L 7-1 42521000516 PSN ASF CR 16MM PLY R 3-1 42521000416 PSN ASF CR 16MM PLY R 3-9 42521000616 PSN ASF CR 16MM PLY R 7-1 42511000518 PSN ASF CR 18MM PLY L 3-1 42511000418 PSN ASF CR 18MM PLY L 3-9 42511000618 PSN ASF CR 18MM PLY L 7-1 42521000518 PSN ASF CR 18MM PLY R 3-1 42521000418 PSN ASF CR 18MM PLY R 3-9 42521000618 PSN ASF CR 18MM PLY R 7-1 42511400810 PSN ASF PS 10MM PLY L 10- 42511401010 PSN ASF PS 10MM PLY L 10- 42511400410 PSN ASF PS 10MM PLY L 3-5 42511400610 PSN ASF PS 10MM PLY L 3-5 42511400510 PSN ASF PS 10MM PLY L 6-9 42511400710 PSN ASF PS 10MM PLY L 6-9 42511400910 PSN ASF PS 10MM PLY L 6-9 42521400810 PSN ASF PS 10MM PLY R 10- 42521401010 PSN ASF PS 10MM PLY R 10- 42521400410 PSN ASF PS 10MM PLY R 3-5 42521400610 PSN ASF PS 10MM PLY R 3-5 42521400510 PSN ASF PS 10MM PLY R 6-9 42521400710 PSN ASF PS 10MM PLY R 6-9 42521400910 PSN ASF PS 10MM PLY R 6-9 42511400811 PSN ASF PS 11MM PLY L 10- 42511401011 PSN ASF PS 11MM PLY L 10- 42511400411 PSN ASF PS 11MM PLY L 3-5 42511400611 PSN ASF PS 11MM PLY L 3-5 42511400511 PSN ASF PS 11MM PLY L 6-9 42511400711 PSN ASF PS 11MM PLY L 6-9 42511400911 PSN ASF PS 11MM PLY L 6-9 42521400811 PSN ASF PS 11MM PLY R 10- 42521401011 PSN ASF PS 11MM PLY R 10- 42521400411 PSN ASF PS 11MM PLY R 3-5 42521400611 PSN ASF PS 11MM PLY R 3-5 42521400511 PSN ASF PS 11MM PLY R 6-9 42521400711 PSN ASF PS 11MM PLY R 6-9 42521400911 PSN ASF PS 11MM PLY R 6-9 42511400812 PSN ASF PS 12MM PLY L 10- 42511401012 PSN ASF PS 12MM PLY L 10- 42511400412 PSN ASF PS 12MM PLY L 3-5 42511400612 PSN ASF PS 12MM PLY L 3-5 42511400512 PSN ASF PS 12MM PLY L 6-9 42511400712 PSN ASF PS 12MM PLY L 6-9 42511400912 PSN ASF PS 12MM PLY L 6-9 42521400812 PSN ASF PS 12MM PLY R 10- 42521401012 PSN ASF PS 12MM PLY R 10- 42521400412 PSN ASF PS 12MM PLY R 3-5 42521400612 PSN ASF PS 12MM PLY R 3-5 42521400512 PSN ASF PS 12MM PLY R 6-9 42521400712 PSN ASF PS 12MM PLY R 6-9 42521400912 PSN ASF PS 12MM PLY R 6-9 42511400813 PSN ASF PS 13MM PLY L 10- 42511401013 PSN ASF PS 13MM PLY L 10- 42511400413 PSN ASF PS 13MM PLY L 3-5 42511400613 PSN ASF PS 13MM PLY L 3-5 42511400513 PSN ASF PS 13MM PLY L 6-9 42511400713 PSN ASF PS 13MM PLY L 6-9 42511400913 PSN ASF PS 13MM PLY L 6-9 42521400813 PSN ASF PS 13MM PLY R 10- 42521401013 PSN ASF PS 13MM PLY R 10- 42521400413 PSN ASF PS 13MM PLY R 3-5 42521400613 P
FDA Enforcement
Class II
·Terminated·Zimmer Manufacturing B.V.·March 23, 2016
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·June 30, 2021
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·June 30, 2021
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
FDA Enforcement
Class II
·Terminated·Baxter Corporation Englewood·February 10, 2016
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
FDA Enforcement
Class II
·Terminated·SA3, LLC·April 13, 2022
SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
FDA Enforcement
Class II
·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022
Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
FDA Enforcement
Class II
·Terminated·Safe N Simple, LLC·July 4, 2018
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
FDA Enforcement
Class II
·Terminated·Safe N Simple, LLC·November 14, 2018
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
FDA Enforcement
Class II
·Terminated·Safe N Simple, LLC·November 14, 2018
DermaPro Waterproof Silicone Tape, SNS57232
FDA Enforcement
Class II
·Terminated·Safe N Simple, LLC·June 20, 2018
RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.
FDA Enforcement
Class II
·Terminated·Baxter Corporation Englewood·May 21, 2014
Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·April 25, 2018
ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020