17 results · 18ms · Sources: EU EUDAMED, US FDA

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STERILE BASIN SETS

FDA 510(k)

Mini Twin

FDA UDI
Rmo, Inc.·00885797674111·MBT MINI LP 018 HK/345 5-5 20EA

SleepmateVelstretch Band Kit, Pediatric

FDA UDI
Ambu A/S·05707480041503·Pediatric Velstretch Band Kit

FG Dental Burs

FDA UDI
BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119311057·

Bioplate®

FDA UDI
Bioplate, Inc.·M3848130120·Self-Drilling Screw - Ø1.5 mm x 4 mm

NTI

FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310813012CFG1·NTI Diamond Coarse FG

Rampart-O

FDA UDI
SPINEOLOGY INC.·M7402813012·Rampart-O

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver

vascuCAP

FDA 510(k)
FDA Class 2 ·Radiology

PROMOS MODULAR SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MAXCUT DIAMOND BURS (6/pk) CRS 6813-012

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D7781006813121·MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size...

MAXCUT DIAMOND BURS (6/pk) MED 813-012

FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D778100813121·MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size...

PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

FDA Adverse Event
Injury ·PENUMBRA, INC.·Product code NRY·May 15, 2014

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·October 31, 2012

ADJ PIN COLLET 2.0-3.2MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 11, 2010

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

FDA Recall
Open, Classified ·BioPro, Inc.·Product code LZY·September 9, 2025

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

FDA Enforcement
Class II ·Ongoing·BioPro, Inc.·October 22, 2025