20 results · 21ms · Sources: EU EUDAMED, US FDA

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DUAL MPC CHARGER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

THD N-Ano Anoscope

FDA UDI
THD SPA·08051887044757·THD N-ano Digital is a disposable medical devic...

Elite Orthopaedics

FDA UDI
Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810053·Blunt Injector, 20G x 4cm, Luer

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100989·KIT, NAR-4 AID w' CELOX GAUZE - COY

Elite Orthopaedics

FDA UDI
Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

iNSitu™ Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127028823·Blade Femoral Broach Size 15

Arthrex®

FDA UDI
ARTHREX, INC.·00888867042292·STAPLE, COMPRESSION, SS, 10I X 15L

VENTRICULAR ANALYSIS TOOLKIT OPTION

FDA 510(k)
FDA Class 2 ·Radiology

DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY

FDA 510(k)
FDA Unclassified ·Unknown

SUPERION INDIRECT DECOMPRESSION SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NQO·April 27, 2021

Horizon XVu

FDA UDI
MENNEN MEDICAL LTD.·07290102932788·Computerized Hemodynamic monitoring System

SONOPET IQ

FDA Adverse Event
Malfunction ·STRYKER CORPORATION·Product code LFL·October 28, 2021

UNK - UNSPECIFIED BY COMPLAINANT

FDA Adverse Event
Injury ·COOK BIOTECH, INC.·Product code FTM·April 3, 2014

TOTALCARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

SMR REVERSE HUMERAL BODY

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 18, 2022

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022