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

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CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

N/A

FDA UDI
Smith & Nephew, Inc.·03596010584755·KEY PERIOSTEAL ELEVATOR 25.4 BL ...

PELVIC FIXATOR

FDA UDI
ORTHOFIX SRL·18053504364832·Component. Not for sale. Used for reporting Dir...

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08806390880671·

Summa Orthopaedics System Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089402687·

MESH URETERAL STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TEMPUS IC PROFESSIONAL PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 25, 2025

TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·January 18, 2017

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 14, 2013

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·May 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

TURBO-JECT POWER INJECTABLE

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·July 3, 2018

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 1, 2015

TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·August 24, 2017

1820334-2020-01805

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·October 5, 2020

EQ REV GLENOID PLATE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·December 13, 2022

TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·June 28, 2018

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021