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

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FIRST RESPONSE PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SCFE Screw

FDA UDI
ORTHOPEDIATRICS CORP.·00841132114704·4.0mm X 58mm SHORT THREAD CANNULATED SCREW

HARDYDISK, CIPROFLOXACIN, 5MCG

FDA 510(k)
FDA Class 2 ·Microbiology

MS-ONE, MODEL MS-1

FDA 510(k)
FDA Class 2 ·Neurology

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·September 27, 2017

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018

J-VAC RESERVOIR

FDA Adverse Event
Malfunction ·ETHICON, INC·Product code KOG·April 2, 2013

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 21, 2011

FLEXVISION U-500 FLEXIBLE URETEROSCOPE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FGB·April 15, 2008

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 21, 2011

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

TSRH

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 29, 2016

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 25, 2011

EVOLUT FX VALVE

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 15, 2025

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

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024