19 results · 27ms · Sources: EU EUDAMED, US FDA

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PANAVIA Veneer LC

FDA 510(k)
FDA Class 2 ·Dental

CABVI/High Five

FDA UDI
Ansell Healthcare Product·10076490785045·CABVI 72-1050XR SIZE XL (9.5-10.0), Powder-Free...

Bosma Enterprises

FDA UDI
Bosma Enterprises·20818634020219·Nitrile Textured Powder Free Exam Gloves Extra ...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154629312·MINI PLATE, PROFILE HEIGHT 1.5MM

16PW - Loggers - Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0105040·Implant Inserter, 11-13mm, Sleeveless

VIDAS CMV IGM 30 TESTS

FDA Adverse Event
Malfunction ·BIOMERIEUX SA·Product code LKQ·March 8, 2021

LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

GALAXY G3 MINI 3MM X 6CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·November 3, 2021

BD PHASEAL¿ OPTIMA INFUSION ADAPTER C100-O

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 23, 2023

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

TOWEL OR 17X24IN GREEN STERILE 4/PK

FDA Adverse Event
Malfunction ·JIANERKANG MEDICAL CO LTD·Product code FRL·December 22, 2021

Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022

PIONEER ANTERIOR CERVICAL PLATE SYSTEM

FDA Adverse Event
Injury ·PIONEER SURGICAL·Product code JDN·October 21, 2008

HS III PROXIMAL SEAL SYTEM 3.8MM

FDA Adverse Event
Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 8, 2011

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015