12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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