14 results · 22ms · Sources: EU EUDAMED, US FDA

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ProLift Micro Expandable Spacer System

FDA 510(k)
FDA Class 2 ·Orthopedic

Philips

FDA UDI
Sbo Hearing A/S·05714464003525·HEARLINK 9010 MNR T, 2.4G NFM DPB DG

BD BBL™ TB Stain Kit ZN

FDA UDI
BECTON, DICKINSON AND COMPANY·00382902125204·BD BBL™ TB Stain Kit ZN Contains: 1 each TB Car...

US-101L, US-103S

FDA 510(k)
FDA Class 2 ·Physical Medicine

GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·March 28, 2025

CLICKLINE

FDA Adverse Event
Malfunction ·KARL STORZ ENDOSCOPY-AMERICA, INC.·Product code GCJ·October 24, 2014

ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

FDA Adverse Event
Malfunction ·CORDIS CORPORATION·Product code NTE·August 16, 2011

TELIGEN

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

BD BBL¿ TB STAIN KIT ZN

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JTS·December 2, 2021

CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

FDA Enforcement
Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

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