24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VUZE System
FDA 510(k)
FDA Class 2
·Radiology
Ormco
FDA UDI
ORMCO CORPORATION·00889989031188·SPRING COIL SPACE WOUND PKG 008 X 030
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023888·BAYONETTED PUSH SCRAPER CURETTE
TRANSDUCER EXTENDING CONNECTOR(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089836·
V/A VIDEO/AUDIO EXTEND MODULE(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089843·
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087069·SOLUTION SYSTEM THINSHAFT REAMER 15.5mm DIA
IDOCK,DATA PORT EXTEND MODULE(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089829·
CW kit
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089515·
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021
TUBING PACK
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DWF·August 1, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·August 12, 2011
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Other
·SI-BONE·Product code OUR·July 2, 2013
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020