16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Anprolene SteriTest
FDA 510(k)
FDA Class 2
·General Hospital
SCHWERT
FDA UDI
A. Schweickhardt GmbH & Co. KG·E8961704270·Osteotome with stop screw
concav...
FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
FDA 510(k)
FDA Class 2
·Cardiovascular
DUPEL TRANSPORT IONTOPHORESIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·July 22, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·May 30, 2018
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
UNK
FDA Adverse Event
Injury
·ZIMMER TRABECULAR METAL TECHNOLOGY·Product code ODP·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 20, 2011
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022