21 results · 24ms · Sources: EU EUDAMED, US FDA

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MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL

FDA 510(k)
FDA Class 2 ·Orthopedic

SPATIAL FRAME

FDA UDI
Smith & Nephew, Inc.·23596010042396·HEX FIX SET SCREW

LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY

FDA 510(k)
FDA Class 2 ·Ophthalmic

HUMPHREY OCT3

FDA 510(k)
FDA Class 2 ·Radiology

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE SUZHOU·Product code ITI·May 14, 2013

ASR UNI FEMORAL IMPL SIZE 47

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·May 19, 2011

FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·August 11, 2008

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

SENSATION PLUS 8FR. 50CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

SENSATION PLUS 7.5FR. 40CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

KIT FLU VERITOR SYSTEM 30 TEST JAPAN

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PLY POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER 16FR. FOLEY, 2 WAY,5cc, Silicone Coated (1) SYRINGE 10cc WATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Enforcement
Class I ·Terminated·Customed, Inc·September 10, 2014

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019

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

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025