19 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BriefCase

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113837·VISCO CANNULA 23GA ANGLE 8MM

3DP Lumbar Interbody System

FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DM2035080·Medium 8-Degree 3DP LLIF - 20mm x 35mm

3DP Lumbar Interbody System

FDA UDI
Genesys Orthopedics Systems LLC·M719GL3DS2035080·Small 8-Degree LLIF - 20mm x 35mm

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996133449·LATERAL,0 DEGREE LORDOSIS

SCORPIO NRG X3 PS TIBIAL INSERT #5 12MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·January 29, 2019

SCORPIO U-DOME X3 PATELLA

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·January 29, 2019

Scorpio

FDA UDI
Howmedica Osteonics Corp.·07613327014570·Universal Dome Patella

STILLE Uterine Curettes

FDA UDI
Stille AB·07332339205997·UTERINE CURETTE RECAMIER STILLE malleable blunt...

Vu a-POD™

FDA UDI
Seaspine Orthopedics Corporation·10889981037987·35x27mm Trial 8mm 8 deg. The Vu a-POD interver...

UNMIAX LAPAROSCOPIC INSTRUMENT

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

NC-STAT

FDA 510(k)
FDA Class 2 ·Neurology

EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 8MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWS·July 10, 2023

RESTORE ADVANCED RECHARGEABLE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code LGW·October 17, 2008

CAPSUREFIX NOVUS

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

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

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