22 results · 6ms · Sources: EU EUDAMED, US FDA

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Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 4, 2026

Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023

Radiography 7300 C; Model Number: 712037;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

ProxiDiagnost N90. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

CombiDiagnost R90 Software Version R1.0 and R1.1

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·September 8, 2021

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

DigitalDiagnost C90 High Performance. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·July 20, 2022

CombiDiagnost R90; Model Number: 709031;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

Precision CRF; Model Number: 706400;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

ProxiDiagnost N90; Model Number: 706110;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems DMC GmbH·November 19, 2025

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·July 6, 2022

Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor. Model: FS32

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·June 23, 2021

Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

FDA Enforcement
Class II ·Ongoing·Skytron, Div. The KMW Group, Inc·April 1, 2020

Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66852 70472 74307 74365 74366 74430 74475 74477 74502 74773 74873 75065 75157 75195 75409 75410 75473 75533 75534 75607 75765 75797 75833 75903 75956 75973 76131 76178 76278 76306 76398 76427 76498 76519 76536 76565 76575 76628 76630 76635 76644 76687 76725 76775 76789 76832 76839 76878 76900 76999 77010 77014 77015 77105 77227 77299 77304 77305 77412 77450 77496 77516 77629 77722 77742 77757 77791 77794 77796 78018 78027 165720 205307A 65046-03 65080-06 65167-06 65934-01 65940-01 66041-01 66154-01 66503-02 70148-02 70178-06 70188-05 70638-07 70664-02 70665-01 70734-03 71064-01 71432-02 71433-01 71546-02 71733-02 71754-04 71801-02 71820-01 71928-06 71934-04 72073-02 72149-01 72226-06 72326-07 73008-02 73346-01 73567-01 73568-01 73776-04 73783-02 73882-03 74172-03 74685-01 74734-01 74833-01 74879-07 74921-02 74965-03 74965-04 74972-01 75030-01 75050-02 75068-01 75159-01 75293-01 75409-01 75409-02 75410-01 75410-02 75540-03 75540-05 75572-01 75642-02 75688-01 75790-02 75834-01 75927-01 75959-01 75972-01 76178-01 76273-01 76278-01 76308-01 76326-02 76372-01 76373-01 76374-01 76376-01 76491-01 76732-02 76873-02 77012-02 77127-01 77316-01 77496-01 77502-01 77521-01 77532-01 77655-01 77791-01 B75409 B75410 B75903 B76178 B76278

FDA Enforcement
Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 10, 2024