14 results · 28ms · Sources: EU EUDAMED, US FDA

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PRIMATRIX DERMAL REPAIR SCAFFOLD

FDA 510(k)
FDA Unclassified ·Unknown

SOFTLASE - SURGICAL DIODE LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ISOBAR SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 27, 2024

VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

FDA Adverse Event
Injury ·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 29, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011

PROSTAR XL SUTURE-MEDIATED CLOSURE

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·July 29, 2008

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 25, 2024

LGN PRSFT STEM 10MMX220MM STRT

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017

CROSS PLATE MTP, RIGHT ANCHORAGE

FDA Adverse Event
Injury ·STRYKER GMBH·Product code HRS·November 21, 2024

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

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

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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