31 results
·
28ms
·
Sources: EU EUDAMED, US FDA
SherpaPak Pediatric Liver Transport System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HHM
FDA UDI
Oticon A/S·05707131353368·G400 S, MINIRITE T 312 2.4G C090 HHM
10M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp
24M - Southwest Gas Corp
FDA UDI
Certified Safety Manufacturing, Inc.·00766588010441·24M - Southwest Gas Corp
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306823756·Ackermann Breast Caliper, 16cm
Quick Connect component p/n 201048. The component is contained in QPC1713 and QPC1724 Quick Connects. The QPC1724 is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K SERIES GI ENDOSCOPES WITH WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without WATER JET to the C1160 Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.
FDA Recall
Terminated
·Steris Corp·Product code MED·August 4, 2008
LIGHT BOND (QUICK CURE)
FDA 510(k)
FDA Class 2
·Dental
THERMOMETER MODELS ST8631
FDA 510(k)
FDA Class 2
·General Hospital
Trilogy® Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024118485·
BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020
MEDTRONIC QUICK SET PARADIGM INSULIN INFUSION SET
FDA Adverse Event
Injury
·MEDTRONIC, INC., DIABETES·Product code FPA·December 28, 2010
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 11, 2016
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 11, 2011
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code OTN·October 20, 2014
6.0MM TI HARD ROD 50MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWQ·July 2, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·October 8, 2010
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·September 30, 2010
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code ESW·October 25, 2010
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·July 11, 2018
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 21, 2020