18 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.

SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE

FDA 510(k)
FDA Class 2 ·Cardiovascular

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125525·PowerChem Neoprene Exam Gloves, Small

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293395·

Sklar®

FDA UDI
SKLAR CORPORATION·10649111127489·F.O. MILLER ENG STYLE SZ1 4MM

KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

FDA 510(k)
FDA Class 2 ·General Hospital

DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

PHOENIX DISPOSABLE PRESSURE TRANSDUCER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2013

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011

ICY HOT HEAT THERAPY PATCH

FDA Adverse Event
Other ·CHATTEM, INC.·Product code IMD·July 2, 2008

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 15, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 20, 2017

TOSOH HLC-723G8 ANALYZER

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·December 11, 2017

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code LCP·January 5, 2016

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Injury ·TOSOH CORPORATION·Product code LCP·January 3, 2017

TOSOH HLC-723G8 ANALYZER G8

FDA Adverse Event
Malfunction ·TOSOH CORPORATION·Product code LCP·April 16, 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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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