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

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gammaCore Sapphire

FDA 510(k)
FDA Class 2 ·Neurology

NorthStar

FDA UDI
Seaspine Orthopedics Corporation·10889981197520·Smooth Shank Poly. Screw, 3.5mm x 46mm

MAXIM ACCEL KNEE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AYCAN WORKSTATION OSIRIX PRO

FDA 510(k)
FDA Class 2 ·Radiology

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

PERFORMANCE TOTAL KNEE PROSTHESIS

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019

PERFORMANCE DISTAL FAB LM/RL MED

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

PERFORMANCE DISTAL FAB LL/RM MED

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

VANGRD CR POR/HA FEM - RT 72.5

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

VANGUARD CR POROUS/HA FEM - RT 72.5

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·March 23, 2016

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

T-SLING

FDA Adverse Event
Injury ·HERNIAMESH S.R.L.·Product code FTL·October 20, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 3, 2013

VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·April 20, 2017

VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·May 12, 2017

Allura Xper FD10; Model Number: 722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

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