18 results
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21ms
·
Sources: EU EUDAMED, US FDA
HOLY DRAGON ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Scope Buddy Plus Tubing
FDA UDI
MEDIVATORS INC.·40677964021976·24 Hour Tubing for FUJIFILM 700 Endoscopes
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981212865·Trial 9w, 10mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450285930·
XIPHOS ZFUZE
FDA UDI
Difusion Technologies, Inc.·00853896008168·PLIF Spacer 29mm Long x 10mm Height
DYNATECH SPD 2000, NUMBER 002-910-0000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AMISTEM C CEMENTED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 31, 2022
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
FDA 510(k)
FDA Class 2
·Clinical Toxicology
IM-9C MICROINJECTORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 220V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 7, 2025
VUELOCK PLATE, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·March 13, 2013
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INT'L LTD·Product code KWA·February 16, 2011
IMPLANTIUM
FDA Adverse Event
Other
·DENTIUM CO., LTD.·Product code DZE·February 22, 2008
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 2016
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024