16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AILERON INTERSPINOUS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664005634·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...
5530 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136020891·5530 3L SYR 1.05OD TAPER OUTLT
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104189·Parallel Connector Closed
SYSLOC MINI V3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
FDA 510(k)
FDA Class 1
·Dental
EXTENDED COATED BLADE
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 1, 2009
EXTENDED COATED BLADE
FDA Adverse Event
Injury
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 1, 2009
LC PCA REFURB 802.11
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code MEA·May 8, 2013
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·August 12, 2008
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021