23 results · 41ms · Sources: EU EUDAMED, US FDA

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IOX CO. LTD.

FDA registration
IOX CO. LTD.·3 products·🇯🇵 Japan

BIOX Instruments Co., Ltd.

Manufacturer
🇨🇳 China

JINJIANG K-BOXING MEN’S WEAR CO.,LTD.

Manufacturer
🇨🇳 China

Biox Instruments Co Ltd

FDA registration
Biox Instruments Co Ltd·2 products·🇨🇳 China

Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

FDA Recall
Terminated ·Invacare Corporation·Product code ITJ·April 6, 2012

Portable X-ray system

FDA Recall
Open, Classified ·DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)·Product code EHD·June 19, 2025

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE

FDA Recall
Terminated ·Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China·Product code GEN·September 20, 2018

HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm

FDA Recall
Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm

FDA Recall
Terminated ·Zhejiang Kindly Medical Devices Co., Ltd. # 758 Binghai Five Rd. Longwan Dist Wenzhou China·Product code FMI·August 24, 2021

MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

FDA Recall
Open, Classified ·Product code FYA·June 1, 2017

Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)

FDA Recall
Terminated ·ShinChang Medical Co., Ltd. 144 1gongdan-Ro Gumi Korea (the Republic of)·Product code FMF·August 24, 2018

MASK

FDA Adverse Event
Malfunction ·DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD·Product code MSH·October 9, 2020

AX-KN95

FDA Adverse Event
Malfunction ·DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD.·Product code MSH·April 19, 2022

Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle

FDA Recall
Terminated ·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004

12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

FDA Recall
Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

medddbase Deutschland GmbH

Importer
🇩🇪 Germany·5 Manufacturers

phoenix Medtech GmbH

Authorized representative
🇩🇪 Germany·66 Manufacturers·1059 Devices

International Associates Auditing & Certification Limited

Authorized representative
🇮🇪 Ireland·46 Manufacturers·161 Devices

KHANG BAO INTERNATIONAL KFT

Authorized representative
🇭🇺 Hungary·119 Manufacturers·1262 Devices

mdi Europa GmbH

Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices