18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033441459·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033441442·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033441435·
RANDOX CARBAMAZEPINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
FDA 510(k)
FDA Class 1
·General Hospital
EQUINOXE REVERSE 38MM GLENOSPHERE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 11, 2023
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 11, 2023
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 21, 2013
UNKNOWN DEPUY LCS 12.5 INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·March 11, 2008
UNKNOWN SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·February 2, 2023
MARKSMAN
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·February 2, 2023
PIPELINE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 2, 2023
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020