14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050184·INHALATION SET, TRACH,AIR-LON - SIZE 5
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306800474·Metzenbaum Scissors, Curved, 20cm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450051634·
basixCOMPAK™
FDA UDI
Merit Medical Systems, Inc.·00884450022818·
AUDIOSCREENER OAE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CHESS HAND SURGERY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
DEPUY PINNACLE 300 ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC·Product code KWA·March 15, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 12, 2011
BIOSENSE WEBSTER NAVISTAR THERMO-COOL
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code DRF·May 23, 2008
Tracheostomy Tubes, Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter) Nylon, item number 1050180 size 3, item number 1050182 size 4, item number 1050184 size 5, item number 1050186 size 6, item number 1050188 size 7, and item number 1050190 size 8.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024