25 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
FDA 510(k)
FDA Class 1
·Ophthalmic
Endeavour™ MD
FDA UDI
METREX RESEARCH, LLC·00615375013908·Endeavour™ MD headlight system - North America,...
Molar Rotation2 Appliance
FDA UDI
Ortho Organizers, Inc.·00190707064440·NITANIUM® MOLAR ROTATOR2 APPLIANCE (28mm)
SCOUTPRO HEMOSTATIC VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
IOLMASTER 500
FDA 510(k)
FDA Class 2
·Ophthalmic
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
CORTSCR Ø2 SELF-DRILL L4 TAN
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code MQN·May 9, 2013
NARROW SCREW REMOVAL PLIERS
FDA Adverse Event
Malfunction
·UMKIRCH·Product code HTC·September 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 10, 2011
MARINR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LPB·November 30, 2016
GALAXY G3 MINI 2.5MM X 5.5CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·August 2, 2021
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021