27 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NANO-CHECK AMI CTNI CARDIAC MARKER TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780164692·Integra® Jarit® Iris Scissors, Supercut, One Se...
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304184893·
ILIZAROV
FDA UDI
Smith & Nephew, Inc.·23596010031291·ILIZAROV DISCLIP-ROUND HOLDS
...
Novo Surgical Inc
FDA UDI
NOVO SURGICAL, INC.·00842331192852·probe w/ eye, stainless steel, 8" (20.3 cm)
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365106385·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131101·IN-OVATION® C Base Rx 018 U3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131611·IN-OVATION® C Roncone 018 U3-3 CS HK
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021310·SPIRA®-A Integrated,Trial, 30x34mm, 15° Lordoti...
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021310·Trial,14mm x 16mm Lordotic 7°, 5mm
LIVESURE BENZODIAZEPINES SCREEN TESTS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LACTOSORB ETHMOID STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·April 23, 2013
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
WRIST SERIES 600 BLOOD PRESSURE MONITOR
FDA Adverse Event
Malfunction
·UNK·Product code DXN·March 17, 2026
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013