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

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Power Wheelchair

FDA 510(k)
FDA Class 2 ·Physical Medicine

BD BBL™ Simmons Citrate Agar Slants

FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210260·BD BBL™ Simmons Citrate Agar Slants, Package of...

FareTec PST

FDA UDI
FARETEC, INC.·B54122210260·FareTec PST Military, green, soft case

SIMPLEX/SARAL

FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007771·1 LEVEL CERVICAL PLATE 26 MM

S2 FEMORAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

FLO-GUARD BREATHING FILTER

FDA 510(k)
FDA Class 2 ·Anesthesiology

CAPTURE-R READY INDICATOR CELLS

FDA Adverse Event
Malfunction ·IMMUCOR, INC.·Product code KSZ·October 3, 2013

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

CD HORIZON LEGACY 5.5

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 12, 2025

UNIFY ASSURA CRT-D

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014

OPTI-FREE MULTI-ACTION UNIT DOSE SOLUTION

FDA Adverse Event
Injury ·ALCON - KAYSERSBERG FRANCE·Product code LPN·May 21, 2013

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.

FDA Enforcement
Class II ·Ongoing·Staar Surgical Company·December 13, 2023

BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018