23 results · 22ms · Sources: EU EUDAMED, US FDA

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WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,

FDA 510(k)
FDA Class 2 ·Cardiovascular

CoRoent

FDA UDI
Nuvasive, Inc.·00887517635556·CoRoent Ant TLIF PEEK, 10x11x34mm 15°

OrthoMedFlex, LLC

FDA UDI
ORTHOMEDFLEX LLC·M7161013450·Femoral Rasp

tremoFlo US Software

FDA UDI
Thorasys Thoracic Medical Systems Inc·07540261013454·tremoFlo Airwave Oscillometry System software c...

WIRE SPECULUM

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896089723·WIRE SPECULUM MINIATURE CLOSED WIRE BLADES

Indus

FDA UDI
SPINEFRONTIER, INC.·00190361035541·Indus Invue MAX Symmetrical ACP, 2 Level, 45mm

ZAVATION

FDA UDI
Zavation LLC·00842166118218·Hook Trial, 4.5mm

Latch Reamer

FDA UDI
BICON, LLC·00813110024336·4.5mm Extended Latch Reamer

Zavation

FDA UDI
Zavation LLC·00197157010003·4.5mm TAP, CANNULATED, NAVLOCK

SYSTEMS INTEGRATION MODEL: ENDOALPHA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

STELLARIS VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022

ESSURE

FDA Adverse Event
CONCEPTUS·Product code HHS·May 3, 2013

LINOX SD 65/16

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code LWS·August 5, 2008

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2011

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016

VITROS ECI IMMUNODIAGNOSTIC SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016