28 results
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Sources: EU EUDAMED, US FDA
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Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,
FDA Enforcement
Class II
·Ongoing·Vascutek, Ltd.·March 11, 2026
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002
FDA Enforcement
Class II
·Ongoing·Applied Medical Resources Corp·April 3, 2024
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·April 13, 2016
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·September 24, 2025
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·March 26, 2014
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
FDA Enforcement
Class II
·Terminated·Mar-Med Co·February 10, 2021
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·March 19, 2014
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·May 14, 2014
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Enforcement
Class II
·Ongoing·MAX LUX CORP·December 8, 2021
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·February 19, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
FDA Enforcement
Class I
·Ongoing·Max Mobility LLC·February 19, 2025
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
Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
FDA Enforcement
Class I
·Ongoing·Mac Medical Supply Co Inc·September 29, 2021
CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
FDA Enforcement
Class II
·Terminated·Del Mar Reynolds Medical, Ltd.·July 31, 2013
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
FDA Enforcement
Class I
·Terminated·Del Mar Reynolds Medical, Ltd.·April 23, 2014