23 results
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27ms
·
Sources: EU EUDAMED, US FDA
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAMLOG
FDA UDI
Preat Corporation·00842092167366·CAMLOG® Screw-Line-compatible 6.0mm Non-Engagin...
KALORE™
FDA UDI
Gc America Inc.·D0470036151·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...
KALORE™
FDA UDI
Gc America Inc.·14548161291309·KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 uniti...
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159019506·Micro Clamp
Zavation
FDA UDI
Zavation LLC·00842166121379·ALIF 0deg 36mm x 15mm
ZAVATION
FDA UDI
Zavation LLC·00842166154759·WHITNEY 0deg 36mmx15mm
ZAVATION
FDA UDI
Zavation LLC·00842166156975·HA+ ALIF 0deg 36mmx15
Zavation
FDA UDI
Zavation LLC·00842166180420·ALIF Sizer 0eg 36mm x 15mm
SECURE FLOW
FDA Adverse Event
Injury
·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012
HUNTER SCIENTIFIC INJECTION PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SURGICAL SYSTEM WITH CRYOGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1X8 SUBCOMPACT LEAD
FDA Adverse Event
Injury
·NEURO - VILLALBA·Product code LGW·May 4, 2017
ON-Q EXPANSION KITS WITH SOAKER CATHETER, 5 IN. (12.5 CM) / NEEDLE 6 IN X 17 G
FDA Adverse Event
Malfunction
·AVANOS MEDICAL, INC.·Product code BSO·January 8, 2021
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code HTJ·February 28, 2013
EXPEDIUM 5.5 MONOAXIAL SCREW 6X40MM, TI
FDA Adverse Event
Injury
·DEPUY SPINE, INC.·Product code MNH·February 22, 2011
EMBRANCE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 20, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024