23 results · 22ms · 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.

LEAD BLOCKS

FDA 510(k)
FDA Class 2 ·Radiology

Vivid NanoFil Unit Dose

FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724D0101720·0.25g x 20 D4

Medallion®

FDA UDI
Merit Medical Systems, Inc.·00884450543931·

VERITON CT

FDA UDI
SPECTRUM DYNAMICS MEDICAL, INC·07290108670127·Single Photon Emission Computed Tomography Syst...

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101120·Distractor, Smooth Paddle, Lordotic, 12mm

UNBRANDED

FDA UDI
FGX INTERNATIONAL INC.·00193033102176·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312L0101120·Distractor, Smooth Paddle, 12mm

UNBRANDED

FDA UDI
FGX INTERNATIONAL INC.·00193033102138·

UNBRANDED

FDA UDI
FGX INTERNATIONAL INC.·00193033102145·

Biosteon® Screw

FDA UDI
BIOCOMPOSITES LTD·15060155711253·The Biosteon® ACL Screw is a cannulated single-...

POLYESTER NONABSORBABLE SURGICAL SUTURES URP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·October 17, 2018

STYLE 68 SALINE FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FWM·June 26, 2023

GYNECARE MORCELLEX* TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·March 19, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·March 1, 2011

VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·March 7, 2008

BD SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 29, 2021

GALAXY G3 MINI 2.5MM X 5.5CM

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·August 2, 2021

Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2 Pediatric Part No. 007606; ;Smart OmniBloc O2 Part No. 010946 Smart OmniLine Plus part No. 010172 Smart OmniLine Plus (package of 100 units) Part No 010212; Smart OmniLine Guardian O2 Part No. 012531; Smart OmniLine Guardian O2 Long Part No. 012532 OmniVentLine Set Part No. 012495

FDA Recall
Terminated ·Oridion Medical·Product code CCK·February 16, 2012