18 results · 33ms · Sources: EU EUDAMED, US FDA

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Symbia VA10A Family

FDA 510(k)
FDA Class 2 ·Radiology

Bernafon

FDA UDI
Bernafon AG·05711584115466·CO1 MNR T, 2.4G NFM MSIL CAPTO 1 GPL

Richard-Allan® Needle 1/2 Circle Taper

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216987·Intent to be used with suture material for tiss...

VERIDIAN

FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000420·ProKit Aneroid Sphygmomanometer With Sprague Sc...

BioHorizons

FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002138·External 6.0mm x 4.5mm Flared Healing Abutment

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383515023·"An absorbent paper points is an endodontic pap...

Spartan Calcar Planer Bushing Spigot

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215114893·

Intellihab System

FDA 510(k)
FDA Class 2 ·Physical Medicine

21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)

FDA 510(k)
FDA Class 2 ·Radiology

INFINION 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 23, 2024

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2008

RENEW SINGLE RECEIVER, 8 CHANNEL

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023