23 results · 83ms · Sources: EU EUDAMED, 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