14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS
FDA 510(k)
FDA Class 2
·General Hospital
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120321191·Diamond, cone rounded edge, COOL DIAMANT, mediu...
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
FDA 510(k)
FDA Class 1
·Dental
RAIN DROP CORNEAL INLAY
FDA Adverse Event
Injury
·REVISION OPTICS/ RVO 2.0, INC·Product code LQE·April 3, 2019
S4 IMPLANTS
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KWP·August 29, 2008
PSN ALL POLY PAT PLY 29MM
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code MBH·February 26, 2026
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 6, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 28, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·April 18, 2008
OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment
FDA Enforcement
Class II
·Ongoing·Lacrimedics Inc·March 9, 2022
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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