949 results · 13ms · Sources: EU EUDAMED, US FDA

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Class IV New Era medical laser device

FDA Recall
Open, Classified ·Inova Lasers LLC·Product code GEX·January 29, 2020

VITROS 5600 Integrated System (New and Refurbished)

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 22, 2024

VITROS 3600 Immunodiagnostic System (New and Refurbished)

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 22, 2024

SMV DSX New Line, System, Tomography, Computed, Emission

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code IYX·December 10, 2025

NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ, SKU 999417

FDA Recall
Open, Classified ·Family Dollar Stores, Llc.·Product code KMF·June 23, 2022

GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code FTM·February 28, 2024

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NSB·April 8, 2024

Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code FTM·February 28, 2024

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

FDA Recall
Open, Classified ·New Standard Device Inc·Product code KTT·December 28, 2020

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

FDA Recall
Open, Classified ·New Standard Device Inc·Product code KTT·July 23, 2019

Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

FDA Recall
Open, Classified ·New Standard Device Inc·Product code HXC·August 14, 2019

GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System

FDA Recall
Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

FDA Recall
Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;

FDA Recall
Open, Classified ·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024

Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OII·March 3, 2025

Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.

FDA Recall
Open, Classified ·DeRoyal Industries Inc·Product code OHM·April 17, 2023

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)

FDA Recall
Open, Classified ·Given Imaging Ltd. New Industrial Park·Product code FFT·June 3, 2025

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

FDA Recall
Open, Classified ·Ethicon, Inc. Us·Product code NEW·August 8, 2022