17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TraumaGuard Intra-abdominal Pressure Sensing System
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
Smith & Nephew, Inc.·03596010511218·PIGGY BACK CONNECTOR 2 PER BOX,
...
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856003378·TI 5.5MM TELESCOPING BRIDGE, 70MM
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776143145·Kleppinger Bipolar Grasping Insert Only
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327620993·3D-plate curved
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981247843·Lamina Hook, 10.5H X 7.0W
Inertia® Pedicle Screw and Deformity Correxxion® System
FDA UDI
NEXXT SPINE, LLC·00889929027288·MAC Pedicle Screw, Ø10.5x70 mm
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
FDA 510(k)
FDA Class 2
·Radiology
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TALENT CAPTIVIA STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 10, 2011
PINNACLE SECTOR II CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 29, 2014
UNIFY ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013
PIGGY BACK (2)
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code FWZ·April 10, 2021
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
FDA Enforcement
Class II
·Terminated·HemoCue AB·September 18, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025