18 results
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20ms
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Sources: EU EUDAMED, US FDA
THEKEN LARGE CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CERASMART™
FDA UDI
Gc America Inc.·14548161320467·CERASMART™ 270 14 Universal A2 LT 5p Block
CERASMART®
FDA UDI
Gc America Inc.·D0470124621·CERASMART 270 14 Unsvl A2 LT 5p
nSpire Health
FDA UDI
NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...
OIL FOR TISSUE CULTURE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)
FDA 510(k)
FDA Class 2
·General Hospital
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 23, 2020
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·November 16, 2012
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions. The treated lesion length should be less than the nominal scaffolding length (8 mm, 12 mm, 18 mm, 23 mm, 28 mm) with reference vessel diameters e 2.0 mm and d 3.8 mm.
FDA Enforcement
Class I
·Terminated·Abbott Vascular·June 7, 2017
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 20, 2013
STERLING BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·March 9, 2011
SPRINTER RX BALLOON CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code LOX·March 12, 2008
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·ICU Medical Inc.·September 10, 2025
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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
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