18 results · 20ms · Sources: EU EUDAMED, US FDA

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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