21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
Smith & Nephew, Inc.·03596010584755·KEY PERIOSTEAL ELEVATOR 25.4 BL
...
PELVIC FIXATOR
FDA UDI
ORTHOFIX SRL·18053504364832·Component. Not for sale. Used for reporting Dir...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08806390880671·
Summa Orthopaedics System Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089402687·
MESH URETERAL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TEMPUS IC PROFESSIONAL PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 25, 2025
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·January 18, 2017
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 14, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
TURBO-JECT POWER INJECTABLE
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·July 3, 2018
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2017
1820334-2020-01805
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·October 5, 2020
EQ REV GLENOID PLATE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 13, 2022
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·June 28, 2018
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
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021