18 results
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20ms
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Sources: EU EUDAMED, US FDA
HUNTER SCIENTIFIC INJECTION PIPETTES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001615·artVeneer life lower anteriors, UCM, BL3
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788022684·Rulo Probe 16g x 15cm w/ 10mm Active Area
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967188232·Battalion, LLIF Trial, 0°, 16 mm Wide, 15 mm X ...
Midmark IQvitals® Device with touchscreen - Blood Pressure, Temperature and SpO
FDA UDI
MIDMARK CORPORATION·00841709100642·Midmark IQvitals® is an affordable, Windows® ba...
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376381084·LIF, BROACH, CC OFFSET 16MM X 15MM
Intervertebral Disc Preparation Instruments
FDA UDI
ALPHATEC SPINE, INC.·00190376380698·LIF, BROACH, STRAIGHT, 16MM X 15MM
ELECSYS THYROGLOBULIN CALCHECK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ULTRA CATHETER SET
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376647043·BROACH, LIF NAV, STRAIGHT, 16MM X 15MM
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 2, 2021
SUPER SOFT PATCHLESS BREAST IMPLANT, 400 CC
FDA Adverse Event
Injury
·DOW CORNING CORP.·Product code FTR·March 31, 1994
HEARTMATE II LVAS, EUROPE
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 11, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·February 25, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 7, 2008
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025