19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARADIGM QUICK-SET INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217757·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01107T0·Cervical Trial, 14 x 11, 7mm, 7 Degree, Tapered
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0110110·Sounder, Ball Tip, Straight, Firm, Titanium
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0110110·Guide, Drill Only, Variable
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01107N0·Cervical Trial, 14 x 11, 7mm, 0 Degree, No Taper
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·B07319K0160710·Curette, Pull, #5
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
FDA 510(k)
FDA Class 2
·Orthopedic
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·BIOFORM MEDICAL·Product code LMH·December 3, 2008
ENDOCARE, CRYOCARE, CRYOPROBE
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 12, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·March 8, 2011
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL AB·Product code DTB·March 10, 2008
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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