19 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PHONAK TINNITUS BALANCE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606593·SPACER 2123450 O25 23.5MM 18 DEG 14X50
VacuumCushion, abdom. S
FDA UDI
MACROMEDICS B.V.·08719425702650·Abdominal vacuum cushion, size S
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 45cm x 130°
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016697·
CASTROVIEJO SYNECHIAE SPATULA
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896013421·CASTROVIEJO SYNECHIAE SPATULA DOUBLE ENDED SEMI...
NEUFLEX
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295017998·NEUFLEX MCP FINGER IMPLANT 50 CEMENTLESS
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIOPSY SITE TISSUE MARKER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
TMJ MEDIUM LEFT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 19, 2024
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
ILS 29MM CURVED
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 26, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
LEFT STANDARD MANDIBULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 19, 2024
TMJ MEDIUM RIGHT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 19, 2024
RIGHT STANDARD MANDIBULAR COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·February 19, 2024
BAIR HUGGER / 3M
FDA Adverse Event
Injury
·3M·Product code DWJ·November 23, 2016
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023