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SEFI MEDICAL INSTRUMENTS

FDA registration
SEFI MEDICAL INSTRUMENTS·1 product·🇮🇱 Israel

MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SYNREAM REAMING ROD Ø2.5 LONG L1150

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HTO·February 26, 2017

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·October 14, 2022

Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex ANSO Needle, 22ga, 1.8mm OD, 5/Bx INS-5323 Sliding stopper INS-5300 "Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD, 5/Bx"

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

Veran Endobronchial: Models: INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter 90 for use w/ Olympus 190 Scopes INS-5905 SPiN Access Catheter 180 for use w/ Olympus Scopes INS-5900 SPiN Access Catheter 90 Degree for use w/ Olympus Scopes INS-5700 SPiN EWC Biopsy Guide Kit

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-2400 SPiN Drive System SYS-2230 ig4 System V2, 230V, 50Hz SYS-2000 ig4 Image Guides System SYS-1500 SPiN View" System SYS-1000 ig4 Image Guides System SYS-0220 ig4 System, 220V, 50Hz SYS-0185 SPiN Planning Laptop Workstation SYS-0128 Planning Workstation w/Monitor SYS-0002 ig4 System INS-7150 SPiN Vision Scope Adapter

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always-On Tip Tracked (AOTT) Brush, 15mm L, 1.8mm OD, 5/Bx" INS-0322 View Peripheral Catheter, 3.2mm OD, 2.0mm WC INS-0305 Always-On Tip Tracked Guidewire, 1.0mm, 950mm INS-0304 Always-On Tip Tracked Guidewire, 1.0mm, 735mm INS-0050 vPad Patient Tracker, 5/Bx INS-0048 vPad Connector Cable

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx Needle

FDA Recall
Open, Classified ·Olympus Corporation of the Americas·Product code JAK·August 10, 2023

RIOMAVIX LTD

Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices