20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
FDA 510(k)
FDA Class 2
·Anesthesiology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00126461·
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00164061·
TruForm
FDA UDI
Rmo, Inc.·00885797099662·MAX MOLAR BDS PEDO ASST 100
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001646·artVeneer life upper anteriors, ITS, BL4
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
FDA 510(k)
FDA Class 2
·Orthopedic
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 12, 2026
LINOX SMART SD 65/18
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013
TRIATHLON PS FEM COMPONENT, CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·February 22, 2011
DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·February 18, 2008
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·May 26, 2022
WAVEWRITER ALPHA? PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 23, 2026
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·December 10, 2021
ATELLICA NEPH 630 SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code JZW·February 21, 2022
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: K05-00203M K05-00511J K05-00547J K05-00612Q K05-00819A K05-01030H K05-01274D K05-01646 K05-01688A K05-01717B K05-01880K K05-01890D K05-01945A K05-01954A K05-02247A K05-02436B K05-02507 K05-02511A K05-02954 K05-02982A To support various vascular or cardiac diagnostic and interventional procedures.
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 21, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016