21 results · 31ms · Sources: EU EUDAMED, US FDA

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VS3 Iridium Sytem

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319744833·Lambotte Osteotome 6-3/4" (16.9cm), 10mm wide, ...

Xsert Lumbar Expandable Interbody System

FDA UDI
Xtant Medical Holdings, Inc.·M697X09212102651·12mm-17mm x 10mm x 26mm x 5° PLIF ASSY

Xsert Lumbar Expandable Interbody System

FDA UDI
Xtant Medical Holdings, Inc.·M697X0921210265STR1·12mm-17mm x 10mm x 26mm x 5° PLIF ASSY (STERILE)

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197388634·Plastic discs (1 pair)

BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Surgical Drills

FDA 510(k)
FDA Class 2 ·Dental

INFINION 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2023

BOXED INCISOR PLUS BL,(BX6)

FDA Adverse Event
Malfunction ·SMITH & NEPHEW, INC.·Product code HAB·November 26, 2019

ENDOPATH ENDOSCOPIC LINEAR CUTTER, 45MM REGULAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 21, 2008

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 11, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

XVWEB

FDA Adverse Event
Injury ·PLANET DDS·Product code LLZ·March 13, 2025

SECOND OPINION

FDA Adverse Event
Injury ·PEARL INC.·Product code MYN·March 13, 2025

ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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.·August 5, 2015

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015