15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ambiT® "PreSet" Ambulatory Infusion Pump
FDA UDI
Avanos Medical, Inc.·00193494001285·ambIT* Pain Control System - Spike Cassette wit...
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005992·ambIT System with Spike Filter Cassette
ELMED
FDA UDI
ELMED INCORPORATED·00842180120983·5 MM DIA., 33 CM INSULATED J-HOOK ELECTRODE, TR...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197163620·CASTROVIEJO Micro Needle Holder,straight
140mm/...
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
FDA 510(k)
FDA Class 1
·Microbiology
MEDAMICUS AXIA RSN
FDA 510(k)
FDA Class 2
·Cardiovascular
REVERSE SHOULDER SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·October 31, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024