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