1,147 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

See DocMan

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGR·November 21, 2024

See DocMan

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·November 21, 2024

See DocMan

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·November 21, 2024

See RES Description

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

See RES description

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

See RES description

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

see RES for description

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

See Luer Cap Set, MPC-130, set, administration, intravascular

FDA Recall
Open, Classified ·Molded Products Inc·Product code FPA·February 17, 2026

See complete list in RES, exceeds character limit. Medline Surgical Gowns

FDA Recall
Open, Classified ·Product code FYA·January 7, 2026

Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.

FDA Recall
Open, Classified ·The See Clear Company·Product code LPL·January 6, 2017

Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223

FDA Recall
Terminated ·Bio-Rad Laboratories Inc·Product code DIO·June 4, 2004

LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert

FDA Recall
Open, Classified ·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024

Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

FDA Recall
Terminated ·Phadia US Inc·Product code DHB·November 20, 2014

MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

FDA Recall
Open, Classified ·Product code LRO·May 4, 2026

Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA

FDA Recall
Terminated ·Bio-Rad Laboratories Inc·Product code DKZ·February 12, 2007

MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)

FDA Recall
Open, Classified ·Product code OGR·May 4, 2026

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

FDA Recall
Terminated ·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013

MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

FDA Recall
Open, Classified ·Product code OEZ·May 4, 2026

MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

FDA Recall
Open, Classified ·Product code OKV·May 4, 2026

MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)

FDA Recall
Open, Classified ·Product code OHD·May 4, 2026