13 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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M-SCAN
FDA 510(k)
FDA Class 2
·Physical Medicine
ArgenZ ST 98x12 ML D2B
FDA UDI
ARGEN CORPORATION, THE·D818130158·Dental porcelain/ceramic restoration kit
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450205686·
REAMER SHAFT, MOD, TRINKLE 8.0X284 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
FDA 510(k)
FDA Class 1
·Dental
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 30, 2013
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 23, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 24, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 30, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 28, 2019
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015