23 results
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83ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Merit Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331160288·callison tissue & tying forceps, tying platform...
N/A
FDA UDI
Ortho Development Corporation·00822409129911·Tibial 2 deg Varus/Valgus Cut Guide w/ Drop Rod...
Navigation Instruments
FDA UDI
VB Spine LLC·10888857379664·Awl Tap Size Ø3.5 mm EVEREST
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 7, 2025
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 17, 2019
LOW PRESSURE BLACK MAX HANDPIECE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 15, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 24, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·January 7, 2015
ADVIA CENTAUR INTACT PTH (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·December 19, 2014
ADVIA CENTAUR XP INTACT PARATHYROID HORMONE (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·November 1, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·February 29, 2016
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·June 15, 2016
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
ADVIA CENTAUR XP INTACT PARATHYROID (IPTH) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CEW·August 30, 2016
MEN'S LIBERTY
FDA Adverse Event
Injury
·BIODERM, INC.·Product code NOA·November 21, 2024