20 results · 22ms · Sources: EU EUDAMED, US FDA

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TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017

MODIFICATION TO: TSRH SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·March 6, 2019

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·August 24, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 10, 2016

LEONE SPA

FDA UDI
LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450213018·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450210444·

ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S

FDA 510(k)
FDA Class 2 ·General Hospital

FG-36UX, FIBER ULTRASOUND GASTROSCOPE

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

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 30, 2021

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 28, 2025

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 2, 2013

SMALL BATTERY DRIVE (COLIBRI)

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HWE·September 15, 2014

PULSE GEN MODEL 102

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 26, 2011

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019