16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOCRETE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
KEY SURGICAL, INC.·00849771048183·K-Wire and Steinmann Pin Dispensers, .054-inch...
LEONE SPA
FDA UDI
LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132127087·2.2/1.25 Drill Guide
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0170040·Driver Shaft, T10 Wedge
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 6, 2025
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
FDA 510(k)
FDA Class 2
·General Hospital
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
FDA 510(k)
FDA Class 2
·Orthopedic
INFANT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 3, 2008
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 22, 2013
SIEMENS BRAND NAME: ARTISTE MV
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·April 18, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
Biolox Ceramic Head XL
FDA Recall
Terminated
·Plus Orthopedics·Product code LZO·February 10, 2004
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026