19 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Procedure Mask, Surgical Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6PW - CPRotector® ONE Deluxe - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White
R1 Reverse Shoulder System
FDA UDI
CATALYST ORTHOSCIENCE INC.·00811596030964·Poly Trial 40mm +0mm
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482001080·Symmetry® Tray, Sterilizing, Medium
SCANLAN® V.I.P™ Instrument Sterilization Trays
FDA UDI
SCANLAN INTERNATIONAL INC·00846159008173·Identification Tags
Flexi-Post Fiber
FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054001379·Flexi-Post Fiber Refill Kit Size 1
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
METHADONE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Batrik PrAmLi Power Enzyme
FDA UDI
Batrik Medical Manufacturing Inc·00690521016699·PrAmLi Power3 Enzymes, Super Concentrate Deterg...
BD HOME SHARPS CONTAINER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 2, 2020
LUGE¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·March 15, 2018
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008
LINOX TD 65/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code LWS·August 9, 2011
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·November 3, 2022
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
FDA Enforcement
Class II
·Terminated·Megadyne Medical Products, Inc.·August 22, 2018