17 results · 23ms · Sources: EU EUDAMED, US FDA

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Elecsys HCG STAT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780402862·Integra® Jarit® Goodhill Ear Forceps 3-3/8" Sha...

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM

BIO-ABSORBABLE CORKSCREW MODEL AR-1920B

FDA 510(k)
FDA Class 2 ·Orthopedic

USG 2000SA

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RESERVOIR 3ML

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 21, 2013

SENSOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·November 17, 2014

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 6, 2015

530G INSULIN PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·February 13, 2015

ENDOVIVE SAFETY PEG KITS PULL METHOD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 17, 2008

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

BIO-CORKSCREW SUTURE ANCHOR

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

SYNCARDIA COMPANION 2 DRIVER

FDA Adverse Event
Malfunction ·SYNCARDIA SYSTEMS, LLC·Product code LOZ·September 30, 2021

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