4,628 results
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8ms
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Sources: EU EUDAMED, US FDA
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·February 21, 2024
Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
FDA Enforcement
Class II
·Ongoing·CP Medical Inc·December 18, 2019
Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC
FDA Enforcement
Class II
·Ongoing·Wondfo USA Co Ltd·June 19, 2024
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
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
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·February 15, 2023
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
MOSAIQ Oncology Information System
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·June 17, 2026
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
FDA Enforcement
Class II
·Ongoing·INSPIREMD Inc·June 17, 2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·May 20, 2026
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·May 20, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
FDA Enforcement
Class II
·Ongoing·MICROVENTION INC.·May 20, 2026
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·May 20, 2026
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
FDA Enforcement
Class II
·Ongoing·Hologic, Inc·May 20, 2026