35 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICRO DIARY SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ZEUS-O
FDA UDI
SPINAL ELEMENTS·00840916122188·Zeus-O Implant, 10 x 09 x 28mm
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00856402006214·Decan Stopper Size 6 Closure 3/4
MOBIS 0°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844001660·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1009280·10mm PLIF Implant 9mm Wide 28mm Length
RONGEUR LEMPERT CURVED 7 1/2"
FDA UDI
W.H. Holden, Inc.·D9281009280·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P10092870·10mm PLIF Implant 9mm Wide 28mm Length 7 Degrees
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
PROLITE VL PULSED LIGHT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 23, 2009
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
COLIBRI
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·September 19, 2014
BARD PERFIX PLUG EXTRA LARGE, MONOFILAMENT KNITTED POLYPROPYLENE
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·May 18, 2011
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·April 11, 2012
Angio Pack, part number AMS6711
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020