30 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·00842331122170·Titanium Bipolar Bayonet Forceps, (malis type) ...
Symetri Clear
FDA UDI
ORMCO CORPORATION·00889989082937·U2R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...
Orthos
FDA UDI
ORMCO CORPORATION·00889989029970·ORTHOS CM SST 019 X 025 UPSM PK10
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198963·AK3 Congruent Insert Trial Size 2, 12mm
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
FDA 510(k)
FDA Class 2
·Cardiovascular
WU'S 3 WHEELED ELECTRICAL SCOOTER, WT-T3H
FDA 510(k)
FDA Class 2
·Physical Medicine
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107620·TRIAL 90-SRK-191212 POLY-MPCS 2X12 RIGHT
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191212801·IN-OVATION® mini EURO 022/UL1 17T 4A
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191212001·IN-OVATION® mini Base Rx 022/UL1 12T 5A
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719121200R1·IN-OVATION® mini Rhodium Base Rx 022/UL1 12T 5A
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 10, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·December 24, 2019
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 2, 2019
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·July 23, 2019
CG FUTURE BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 15, 2018
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·March 8, 2023
ULTRACISION HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 26, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 29, 2011