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

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VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827851·***DISC*LEVAMED ANKLE SUPPORT BLACK III

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482038697·Symmetry® Probe, Double-Ended, Stainless Steel,...

Phonak

FDA UDI
Phonak AG·07612847817517·Phonak Ambra microM (pure transparent)

CARDIAC VIEW, MODEL 2001

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00842962108727·PROBE, 5 1/8", DOUBLE ENDED, SS

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

ILIAC SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

QUICK FLEX LV LEAD

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·May 2, 2013

INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·September 15, 2014

THERMATRX OFFICE THERMO THERAPY SYSTEM

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MEQ·April 19, 2011

POLARIS SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020

POLARIS TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024