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

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BNF

FDA 510(k)
FDA Class 2 ·Orthopedic

ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0

FDA 510(k)
FDA Class 2 ·Anesthesiology

RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR

FDA 510(k)
FDA Class 2 ·Orthopedic

audifon

FDA UDI
audifon GmbH & Co. KG·EADF0217828316312017201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021782831632517201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF0217828316338217201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF0217828316315917201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF0217828316312717201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021782831631317201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021782831631217201·RITE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF0217828316338117201·RITE-TRT

SLIDE/FIXED HAMMER 700 GRAMS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code FZY·March 26, 2013

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011

QUADRA ASSURA DR CRT-D

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·August 19, 2014

Y-90 THERASPHERE

FDA Adverse Event
Death ·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 11, 2023

WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 8, 2021

Y-90 THERASPHERE

FDA Adverse Event
Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 11, 2023

DHF 06 HEMOCONCENTRATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.

FDA Enforcement
Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018