10 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LAMINARIA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225299·Exodontia Oral Gauze Dir. & Ligature Tucker #2522
On Call Express Mobile Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Z3D CONTRAST ACUITY
FDA 510(k)
FDA Class 2
·Radiology
GENTLEMAX PRO
FDA Adverse Event
Malfunction
·CANDELA CORP.·Product code GEX·April 9, 2014
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 15, 2010
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 19, 2012
Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024