15 results · 25ms · Sources: EU EUDAMED, US FDA

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NeedleCam HD Visualization System

FDA 510(k)
FDA Class 2 ·Orthopedic

PINTLER PATIENT WARMING SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

LOW PROFILE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

BELLATEK® ABUTMENT TSV 3.5MM

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

ABUTMENT, PATIENT SPECIFIC, TITANIUM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

BELLATEK ABUTMENT TSV 4.5MM

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

PINNACLE PELVIC FLOOR REPAIR KITS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 3, 2011

BATTERY REAMER/DRILL

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code MOQ·October 6, 2014

EAGLE EYE PLATINUM SHORT TIP

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

EAGLE EYE PLATINUM SHORT TIP; EAGLE EYE PLATINUM ST CATHETER

FDA Adverse Event
Injury ·VOLCANO CORPORATION·Product code OBJ·July 1, 2016

Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0.75 mL, Total Length 10''; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·August 3, 2005