23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100500·Caddie, 4.75mm Screws
FIT TEST C&B
FDA 510(k)
FDA Class 2
·Dental
LMA FLEXIBLE, REU, SIZE 5 (110050)
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAE·February 23, 2017
Corin BiPolar-i
FDA UDI
CORIN LTD·05056139233968·Acetabular Trial Ø50
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776020750·Slotted U Bracket
OCS-B Collagen
FDA UDI
Nibec Co., Ltd.·08809186549516·OCS-B Collagen® is a combination of purified ca...
Straumann XenoFlex
FDA UDI
Nibec Co., Ltd.·08809186541787·Straumann XenoFlex® is a combination of purifie...
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521110050D0·10 x 50 mm Anodized SI Implant Fully Threaded
Orthoblast II Putty
FDA UDI
ISOTIS ORTHOBIOLOGICS, INC.·10889981055622·OrthoBlast II Putty, 5cc - derived from selecte...
R & D SYSTEMS XERET HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMISTEM C CEMENTED STD STEM SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 6, 2022
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 13, 2013
SYBRONPRO TL
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·June 1, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·August 14, 2008
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Recall
Terminated
·LeMaitre Vascular, Inc.·Product code KFX·March 18, 2013
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
FDA Enforcement
Class II
·Terminated·LeMaitre Vascular, Inc.·April 10, 2013
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014