13 results
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26ms
·
Sources: EU EUDAMED, US FDA
STERILE TRACHEOSTOMY CARE KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CODMAN® ACCU-FLO®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780536871·CODMAN® ACCU-FLO® Straight Connector Stainless ...
CODMAN® ACCU-FLO®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517566·CODMAN® ACCU-FLO® Straight Connector Stainless ...
CODMAN ACCU-FLO
FDA UDI
Cerenovus, Inc.·10886704040361·CODMAN ACCU-FLO Straight Connector Stainless Steel
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268215011·CUSTOM SURGICAL KIT ENDOVENOUS PACK
REACH TOTAL CARE PLUS WHITENING TOOTHBRUSH
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON CONSUMER PRODUCTS·Product code EFW·April 3, 2013
ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)
FDA 510(k)
FDA Class 2
·General Hospital
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HISTOACRYL BLUE 0.5 ML
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code MPN·January 15, 2014
LRG TAP PRI MOD NCK 0DEG 30MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·October 23, 2012
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 25, 2010
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021