13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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16 ch Tx/Rx Knee SPEEDER
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
MaxFuse,VBR, 12 (D) x 14 (W) x 32 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056278·VBR, 12 (D) x 14 (W) x 32 (H)
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCU-SOURCE
FDA 510(k)
FDA Class 2
·Radiology
VERTE-STACK® SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code MQP·October 8, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 7, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·July 6, 2011
D902 LILLIPUT ECMO M PHISIO
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022
LILLIPUP PMP, LILLIPUT PMP INTEGRATED
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020