14 results · 21ms · Sources: EU EUDAMED, US FDA

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VERSAVIT

FDA 510(k)
FDA Class 2 ·Ophthalmic

LARGE CANNULATED SCREWS

FDA UDI
Smith & Nephew, Inc.·03596010064219·CANNULATED HIP PIN 135MM

VU C*POD INTERVERTEBRAL BODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

ARROW-LOK DIGITAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BD SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019

RESPIRONICS V60

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code CBK·April 4, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 26, 2014

UNKNOWN DEPUY TIBIAL INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 2, 2011

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015