20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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