17 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STATZYME GLUCOSE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056240·WIRE NI-TEK UPPER .016X.022 PKG/10
NuVasive
FDA UDI
Nuvasive, Inc.·00887517263742·Universal Mallet, Cervical
NA
FDA UDI
KEY SURGICAL, INC.·00849771048152·K-Wire and Steinmann Pin Dispensers, .028-inch...
CONMED
FDA UDI
Conmed Corporation·20653405008849·BIPOLAR ELECTROSURGICAL FORCEPS, 5-1/2" SEMKIN ...
Monosyn Quick Synthetic Absorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAP-TRAY II (CATALOG #C600-2)
FDA 510(k)
FDA Class 1
·Pathology
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·October 3, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·November 13, 2007
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·December 18, 2013
MONOSYN QUICK
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 20, 2022
MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2026
MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023
MONOMEND ST5/0 18"(45CM)DSMP11(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·January 2, 2023
MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 25, 2026
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 30, 2025