19 results · 15ms · Sources: EU EUDAMED, US FDA

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GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

FDA Enforcement
Class II ·Ongoing·Sonendo Inc·November 23, 2022

Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·August 14, 2024

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pack Number DYNJ63532; 7) BASIC PACK, Pack Number DYNJ81702; 8) BASIC PACK, Pack Number DYNJ36595D; 9) BASIC PACK, Pack Number DYNJ69250A; 10) BEACH CHAIR SHOULDER PACK, Pack Number DYNJ50470C; 11) BGMC ADULT HERNIA PACK-LF, Pack Number DYNJ0115839A; 12) BMT EP PROCEDURE PACK-LF, Pack Number PHS396134006A; 13) CABG PACK, Pack Number DYNJ20114Q; 14) CABG UNIVERSITY HOSP PACK-LF, Pack Number DYNJ0375705L; 15) CHEST PACK SC-LF, Pack Number DYNJ38051F; 16) CHOM START UP PACK-LF, Pack Number DYNJ0161358B; 17) CHS RFT TOTAL KNEE PACK, Pack Number DYNJ50844B; 18) COMPOSITE NECK DISSEC SHSC-LF, Pack Number DYNJ46776C; 19) COMPOSITE RESECTION PACK, Pack Number DYNJ40640B; 20) CSTM PK DRP SURG MIN PK LGRAY, Pack Number DYNJ39385; 21) CT BASIC PACK, Pack Number DYNJ51617A; 22) CUSTOM LID PACK-LF, Pack Number DYNJ06672I; 23) CYSTO, Pack Number DYNJ24351D; 24) CYSTO PACK, Pack Number DYNJ62359A; 25) DAVINCI PACK, Pack Number DYNJ04113C; 26) DUPYTRENS PACK, Pack Number DYNJ60496; 27) EH PACEMAKER PACK, Pack Number DYNJ55734C; 28) EVLT PACK, Pack Number DYNJ45997C; 29) FH MINOR GENERAL PK-LF, Pack Number DYNJ51799G; 30) GENERAL BASIC PACK, Pack Number DYNJ82039; 31) GENERAL PURPOSE CV, Pack Number DYNJ904395F; 32) GENERAL UTILITY PACK, Pack Number DYNJ45093B; 33) HP DEVICE-LF, Pack Number DYNJ62255A; 34) INTERVENTIONAL RADIOLOGY PACK, Pack Number DYNJ42231B; 35) IR PACK, Pack Number DYNJ32080L; 36) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857; 37) IR TABLE PACK II, Pack Number DYNJ56298B; 38) JVL-PACK TUNNELED, Pack Number DYNJ66065; 39) LITHOTOMY PACK, Pack Number DYNJ66490B; 40) LITHOTOMY PACK, Pack Number DYNJ65380A; 41) LOOP RECORDER PACK, Pack Number DYNJ53221B; 42) LOOP RECORDER PROCEDURE, Pack Number DYNJ48058A; 43) MAJOR BASIN PACK, Pack Number DYNJ67484A; 44) MAJOR PACK, Pack Number DYNJ51996; 45) MAJOR PACK-LF, Pack Number DYNJ24599I; 46) MINI PACK, Pack Number DYNJ52305D; 47) MINI SET UP KIT, Pack Number DYNJ81562; 48) MINOR BASIN, Pack Number DYNJ43021B; 49) MINOR LITHOTOMY NO GOWNS, Pack Number DYNJ69286; 50) MINOR PACK-LF, Pack Number DYNJ0551383P; 51) MINOR PK-LF, Pack Number DYNJ21408D; 52) MINOR WAKEFIELD, Pack Number DYNJ58872A; 53) MYELOGRAM TRAY, Pack Number DYNDH1775A; 54) OB PACK, Pack Number DYNJ32216B; 55) OPEN STERILE PACK, Pack Number DYNJ62104A; 56) PACK PROCEDURE NO DRAPE, Pack Number DYNJ60124B; 57) PACK URO-BASIC, Pack Number DYNJ38246A; 58) PACK,LTD BODY SSP, Pack Number DYNJ65488B; 59) PARACENTESIS, Pack Number DYNJ44505B; 60) PBMS NECK PACK-LF, Pack Number DYNJ64961A; 61) PEDI MAJOR PACK, Pack Number DYNJ40062K; 62) PEDI PK-LF, Pack Number DYNJ21240J; 63) PEDIATRIC MINOR PACK, Pack Number DYNJ51725B; 64) PEDIATRIC PACK-LF, Pack Number DYNJ55355B; 65) PK, GEN-MINOR, Pack Number DYNJ59461C; 66) PK, GEN-MINOR-ABCESS, Pack Number DYNJ43754B; 67) PK, URO-CYSTO-MH, Pack Number DYNJ62501; 68) PK-GEN-BASIC, Pack Number DYNJ42382B; 69) PLASTIC - BBR ABD UNIV-LF, Pack Number DYNJ41824B; 70) PODIATRY PACK, Pack Number DYNJ37297D; 71) PST PACK, Pack Number DYNJ62666; 72) RR-ROBOTIC PROSTATECTOMY PK-LF, Pack Number DYNJ0785683J; 73) SHORT PROCEDURE PACK, Pack Number DYNJ43502A; 74) SHUNT PACK-LF, Pack Number PHS967363W; 75) SILICON/WAVERLY BASIC PACK, Pack Number DYNJ30242; 76) SPECIAL BASIC TRAY-LF, Pack Number DYNJ0129513X; 77) STANDARD ICL PACK-LF, Pack Number PHS895675B; 78) T & A PK-LF, Pack Number DYNJT2408C; 79) THORACIC PACK SHD, Pack Number DYNJ68416C; 80) TONSIL PACK-LF, Pack Number DYNJ0553334I; 81) TRANSPLANT BENCH-UNIV-LF, Pack Number DYNJ0375928I; 82) ULTRASOUND PACK-LF, Pack Number DYNJ0416615M; 83) VASECTOMY PACK, Pack Number DYNJ65326; 84) VASECTOMY PACK,

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 2, 2025

BD Pyxis Mini Main REF: 349 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation ES REF: 323 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

FDA Enforcement
Class II ·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023

BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedStation ES Tower REF: 352 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

FDA Enforcement
Class II ·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024

CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST

FDA Enforcement
Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

FDA Enforcement
Class II ·Ongoing·AMD Medicom Inc.·June 24, 2026

Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

FDA Enforcement
Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026

Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

FDA Enforcement
Class II ·Ongoing·Securitas Healthcare LLC·January 14, 2026