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

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ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

FDA 510(k)
FDA Class 2 ·Microbiology

REPROCESSED DISPOSABLE TROCARS

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code HSD·August 28, 2023

ARTICULEZE M HEAD 36MM +8.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 27, 2008

AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

FDA Adverse Event
CARROLL HEALTHCARE·Product code FNL·August 17, 2011

LIBERTY CYCLER

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 3, 2013

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024