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

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OnX Tough

FDA 510(k)
FDA Class 2 ·Dental

WEITLANER RETRACTOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896077287·WEITLANER RETRACTOR BLUNT TIPS EXTENDED BLADE S...

POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

VAULT ALIF SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·January 23, 2009

RENEGADE HI-FLO MICROCATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code KRA·November 7, 2008

ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 1, 2011

INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

BD PEGASUS

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·October 29, 2023

VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS-FREIBURG·Product code HRS·August 27, 2013

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

FDA Enforcement
Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

CODMAN Disposable Perforator, 14mm. Cranial perforator.

FDA Enforcement
Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025