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