19 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668108970·ARBISSER ANTERIOR CHAMBER CANNULA 27GA

Neocis Guidance System

FDA UDI
NEOCIS INC·00810004900479·Rayscan RCT700 Chin Rest

POINT 4 MODIFIED

FDA 510(k)
FDA Class 2 ·Dental

INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

FDA 510(k)
FDA Class 2 ·Radiology

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 8, 2025

Truliant CC

FDA UDI
Exactech, Inc.·10885862626219·TRULIANT AUG. BLOCK TRIAL SZ 3, 15MM DIST/10MM ...

Optetrak Logic

FDA UDI
Exactech, Inc.·10885862287564·SZ 3 LGC AUG. BLCK TRIAL 15MM DIST/10MM POST

Optetrak Logic

FDA UDI
Exactech, Inc.·10885862287663·

Truliant CC

FDA UDI
Exactech, Inc.·10885862613059·TRULIANT AUG. BLOCK SZ 3, 15MM DIST/10MM POST

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2013

TURBOHAWK

FDA Adverse Event
Malfunction ·EV3 INC.·Product code MCW·April 22, 2011

RIATA PASSIVE FIXATION LEAD

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

TITAN OTR NAR SCRO 16CM

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code FHW·September 6, 2018

UNKNOWN HIP FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 3, 2021

TRI-LOCK BPS SZ 4 HI OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·November 4, 2015

TRI-LOCK BPS SZ 7 STD OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC·Product code KWA·November 4, 2015

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018