22 results · 35ms · Sources: EU EUDAMED, US FDA

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FAST SET PUTTY

FDA 510(k)
FDA Class 2 ·Neurology

HI-TORQUE CONNECT

FDA UDI
ABBOTT VASCULAR INC.·08717648174995·Hi-Torque Connect Guide Wire .018" 300 cm

DOCKERS

FDA UDI
FGX INTERNATIONAL INC.·00193033427828·

DOCKERS

FDA UDI
FGX INTERNATIONAL INC.·00193033427842·

DOCKERS

FDA UDI
FGX INTERNATIONAL INC.·00193033427835·

OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

MICROWAVAE DELIVERY SYSTEM #MW2000

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

BD POSIFLUSH¿ SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2018

HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

FDA Enforcement
Class II ·Terminated·Abbott Vascular, Inc.·January 1, 2014

UNKNOWN VERSASTEP

FDA Adverse Event
Malfunction ·COVIDIEN·Product code GCJ·June 11, 2015

IMP,TSV,4.1MM,SBM,13

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 20, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·February 28, 2011

SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

FDA Adverse Event
Injury ·OBTECH MEDICAL SARL·Product code LTI·March 12, 2008

IMP,TSV,4.1MM,SBM,10

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 21, 2025

IMP,TSV,4.1MM,SBM,11.5

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 18, 2024

IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·November 1, 2023

HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

FDA Recall
Terminated ·Abbott Vascular, Inc.·Product code DQX·November 25, 2013

UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019