16 results · 27ms · Sources: EU EUDAMED, US FDA

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Claritas iPET

FDA 510(k)
FDA Class 2 ·Radiology

MaXcess

FDA UDI
Nuvasive, Inc.·00887517190727·MaXcess Access Blade, 140mm Center

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704514858·

3M™ Unitek™

FDA UDI
3M UNITEK CORPORATION·00652221049070·Unitek(TM) Permachrome Resilient Stainless Stee...

Photodynamic Bone Stabilization System

FDA UDI
ILLUMINOSS MEDICAL, INC.·M986US22131400·22/13mmx140mm Photodynamic Bone Stabilization L...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197312660·Cottle Septum Knife with r...

VARI-LASE WIREFIBER LASER FIBER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

NA

FDA UDI
GENDRON, INC.·00842307100034·STRETCHER,CHR FRM,ENAM LTR, UTILITY SHELF

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

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

NA

FDA UDI
GENDRON, INC.·00842307102281·STRETCHER,CHR FRM,ENAM LTR INCLUDES: ...

ENDOVIVE? JEJUNAL FEEDING TUBE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNT·October 30, 2014

HALO 360 ABLATION CATHETER

FDA Adverse Event
Malfunction ·BARRX MEDICAL, INC.·Product code GEI·August 11, 2011

SELUTE PICOTIP

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

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