16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Lumify Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
K-Systems
FDA UDI
RESEARCH INSTRUMENTS LIMITED·05060554120291·Assisted Reproduction Accessories
Sklar®
FDA UDI
SKLAR CORPORATION·10649111350931·SKLARLITE XD HARTMANN STR 3.5"
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668103098·GIRARD SYNECHIAE SPATULA
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702777796·ELVAREX 2/KNEE HIGH/OPEN TOE-ELEPHANTIASIS-VERS...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702647150·ELVAREX FORTE 3/THIGH HIGH/SLANT-CLOSED TOE-ELE...
Spray Catheter
FDA UDI
Micro-Tech (Nanjing) Co., Ltd.·06932503562300·Blue handle 2.3mm OD 2500mm length
MODIFICARION TO WACKERS-LIU CQ SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMP,TSV,3.7,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 20, 2022
GE OEC APIX TABLE
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
KENSTONE METAL·Product code INP·September 2, 2011
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 18, 2013
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014