22 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FENNING HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
GRADIA®
FDA UDI
Gc America Inc.·D0470024411·GRADIA® ENAMEL INTENSIVE EI0
GRADIA®
FDA UDI
Gc America Inc.·14548161322119·GRADIA® ENAMEL INTENSIVE EI0
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BODYGUARD
FDA 510(k)
FDA Class 2
·General Hospital
2520274-2013-01465
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·March 13, 2013
K-WIRE CUTTING PLIERS (MAX 1.6MM)
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·January 28, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 12, 2014
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 17, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 17, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 17, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·August 15, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025
COMPR VRS GLEN PPS MIN TPR ADR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 4, 2022
UNKNOWN LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 4, 2022
UNKNOWN LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·February 4, 2022
PENUMBRA SMART COIL DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·February 9, 2021
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