15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
LITTLE ANGELS SWADDLING BLANKET
FDA 510(k)
FDA Class 2
·General Hospital
Alpha 1 Acid Glycoprotein RID plate package
FDA UDI
KENT LABORATORIES INC·B1761234·Radial immunodiffusion plate package for Human ...
IDEAL IQ SOFTWARE OPTION
FDA 510(k)
FDA Class 2
·Radiology
STEELEX STERNUM SET
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·August 17, 2018
2032227-2019-123411
FDA Adverse Event
Malfunction
·Product code OYC·November 27, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
ACCUSURE
FDA Adverse Event
Malfunction
·FEEL TECH·Product code FMF·December 17, 2008
LCP 4.5/5 BROAD CURV 14HO L265 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·February 19, 2025
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·February 19, 2025
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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