18 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM
DIAMOND-5A/6A/8A
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
SprintRay Apex Base - Opaque Original Pink - 1 Kg
FDA UDI
Sprintray, Inc.·00850039704680·APEX Base resin is a light-curable polymerizabl...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
LATEX ULTRASONIC PROBE COVER
FDA 510(k)
FDA Class 2
·Radiology
APPRAISE URINE MICROALBUMIN COLLECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
GE OEC 8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 28, 2013
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·November 4, 2021
ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·April 14, 2021
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·March 31, 2022
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA - PRINCETON·Product code GXQ·March 31, 2022
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021