75 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·January 12, 2022
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
FDA Enforcement
Class II
·Ongoing·Invacare Corporation·June 1, 2022
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
FDA Enforcement
Class II
·Ongoing·Stradis Healthcare·January 18, 2023
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6) BREAST/MINOR, Pack Number CDS980228W ; 7) PLASTIC CDS , Pack Number CDS980232U ; 8) PLASTIC CDS , Pack Number CDS980232V ; 9) PLASTIC CDS , Pack Number CDS980232W ; 10) PLASTIC CDS , Pack Number CDS980232X ; 11) LTP CDS-LF, Pack Number CDS980375L ; 12) PLASTIC CDS , Pack Number CDS980457R ; 13) PLASTIC CDS , Pack Number CDS980457S ; 14) PLASTIC CDS , Pack Number CDS980457T ; 15) BREAST AUG, Pack Number CDS980567R ; 16) BREAST AUG, Pack Number CDS980567S ; 17) LARGE PROCEDURE-LF, Pack Number CDS981257J ; 18) LARGE PROCEDURE-LF, Pack Number CDS981257K ; 19) BREAST CDS, Pack Number CDS981691N ; 20) MAJOR PLASTICS CDS, Pack Number CDS981958I ; 21) MAJOR PLASTIC CDS-LF, Pack Number CDS981978J ; 22) MINOR PLASTIC , Pack Number CDS982018K ; 23) MAJOR BREAST, Pack Number CDS982038S ; 24) VASAL RECONSTRUCTION, Pack Number CDS982042O ; 25) MINOR BREAST, Pack Number CDS982053M ; 26) MINOR BREAST, Pack Number CDS982053N ; 27) MINOR BREAST, Pack Number CDS982053O ; 28) MINOR BREAST, Pack Number CDS982053P ; 29) BREAST AUGMENTATION , Pack Number CDS982254K ; 30) BREAST AUGMENTATION , Pack Number CDS982254L ; 31) BREAST AUGMENTATION , Pack Number CDS982254M ; 32) BREAST REDUCTION CDS, Pack Number CDS982255G ; 33) BREAST REDUCTION CDS, Pack Number CDS982255I ; 34) BREAST REDUCTION, Pack Number CDS982255J ; 35) TYMPANOPLASTY , Pack Number CDS982720M ; 36) MAJOR BREAST CDS SJF-LF , Pack Number CDS982730M ; 37) REDUCTION CDS , Pack Number CDS982776J ; 38) REDUCTION CDS , Pack Number CDS982776K ; 39) REDUCTION CDS , Pack Number CDS982776L ; 40) HMT MAJOR BREAST/PLASTICS CDS , Pack Number CDS982860R ; 41) MAG PLASTIC CDS , Pack Number CDS982909I ; 42) MAG PLASTIC CDS , Pack Number CDS982909J ; 43) MAG PLASTIC CDS , Pack Number CDS982909K ; 44) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910K ; 45) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910L ; 46) MAG BREAST RECONSTRUCTION CDS , Pack Number CDS982910M ; 47) MAG FREE FLAP CDS-LF, Pack Number CDS982911K ; 48) GENERAL BREAST, Pack Number CDS983058G ; 49) GENERAL BREAST, Pack Number CDS983058I ; 50) BASIC PLASTIC CDS-LF, Pack Number CDS983141C ; 51) BASIC PLASTIC CDS-LF, Pack Number CDS983141D ; 52) BREAST CDS, Pack Number CDS983148A ; 53) BREAST CDS, Pack Number CDS983148B ; 54) ZALE STEREOTACTIC CDS , Pack Number CDS983173I ; 55) CUH ABDOMINOPLASTY CDS, Pack Number CDS983176I ; 56) MAJOR CDS , Pack Number CDS983292D ; 57) PECTUS REPAIR , Pack Number CDS983353R ; 58) PECTUS REPAIR , Pack Number CDS983353S ; 59) PECTUS REPAIR , Pack Number CDS983353T ; 60) PECTUS REPAIR , Pack Number CDS983353U ; 61) PECTUS REPAIR , Pack Number CDS983353V ; 62) PECTUS REPAIR , Pack Number CDS983353X ; 63) MAMMOPLASTY-LF, Pack Number CDS983478J ; 64) MAMMOPLASTY-LF, Pack Number CDS983478K ; 65) MAMMOPLASTY-LF, Pack Number CDS983478L ; 66) PLASTICS FREE FLAP, Pack Number CDS983493L; 67) PLASTICS FREE FLAP, Pack Number CDS983493M; 68) PLASTIC TORSO-LF, Pack Number CDS983496I ; 69) PLASTIC TORSO-LF, Pack Number CDS983496J ; 70) PLASTIC TORSO-LF, Pack Number CDS983496K ; 71) PLASTIC TORSO-LF, Pack Number CDS983496L ; 72) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498I ; 73) PLASTIC HEAD AND NECK-LF, Pack Number CDS983498J ; 74) ACH PLASTICS BREAST-LF, Pack Number CDS983639C ; 75) ACH PLASTICS BREAST-LF, Pack Number CDS983639D ; 76) ACH PLASTICS BREAST-LF, Pack Number CDS983639G ; 77) ACH PLASTICS BREAST-LF, Pack Number CDS983639I ; 78) ACH PLASTICS BREAST-LF, Pack Number CDS983639J ; 79) ACH PLASTICS BREAST-LF, Pack Number CDS983639K ; 80) NE BREAST AUGMENTATION CDS, Pack Number CDS983660C ; 81) NE BREAST RECON CDS , Pack Number CDS983660D ; 82) NE BREAST RECON
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Firestone Supplemental - w/Logo; (2) KR614-020 16R - Firestone Supplemental - Refill; (3) K616-033 36M - Class A Office - Metal; (4) KR616-006 36R - Class A Office - Refill; (5) KR616-015 75R - Class A Office - Refill; (6) K616-015 75V - Class A Office - 3-Shelf Cabinet; (7) K618-016 EMT - Duke Energy TD - Red Bag; (8) KR618-016 EMTR - Duke Energy TD - Refill; (9) K616-008 FAC-3 - Class B + Meds - 3 Shelf Cabinet; (10) KR616-008 FAC-3R - Class B + Meds - Refill; (11) K618-013 FAC-3 - Five Star Safety - w/Logo; (12) K611-044 FAC-3 - Uline 100 person - w/Logo; (13) K620-609 FAC-3 - Uline Class B + Meds - w/Logo; (14) K616-072 FAC-4 - Choate Construction - w/Logo; (15) KR616-072 FAC-4R - Choate Construction - Refill; (16) K616-066 FAC-4 - Class B + Meds - 4 Shelf Cabinet; (17) KR616-066 FAC-4R - Class B + Meds - Refill; (18) K612-159 FAC-4 - Uline - w/Logo - w/Contents sticker; (19) K616-067 FAC-5 - Class B - 5 Shelf Cabinet; (20 KR616-067 FAC-5R - Class B - Refill
FDA Enforcement
Class II
·Ongoing·Certified Safety Mfg Inc·May 18, 2022
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
FDA Enforcement
Class II
·Ongoing·Seiler Instr. & Mfg. Co. Inc.·April 11, 2018
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
FDA Enforcement
Class II
·Ongoing·Young Dental Mfg Co I LLC·February 9, 2022
Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026