15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814749·GENUMEDI EXTRA WIDE SAND SIZE VI
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00874750005499·7450 V2 PET MASK W/HG/FLEX MA
AVATAR Minimally Invasive Spinal System
FDA UDI
Life Spine, Inc.·00190837052515·Pre-Lordosed 5.5mm Rod Caddy - Odd Lengths
COHESION BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STEM: AMISTEM H HA COATED LAT STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 6, 2020
VERSAFITCUP DM HIGHCROSS ACETABULAR LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·September 6, 2013
MONGOOSE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 15, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014
HUDSON INCENTIVE SPIROMETER LUNG/VOL EXERCISER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BWF·May 17, 2011
VITEK MS INSTRUMENT
FDA Adverse Event
Malfunction
·BIOMÉRIEUX, SA·Product code QBN·April 15, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025