20 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ND: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A.S.A.P.® Diamond Polishing Brushes 6-Pack
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172017145·Dental abrasive disk
A.S.A.P.® Diamond Polishing Brushes 6-Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883003760·Dental abrasive disk
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
FDA 510(k)
FDA Class 1
·Dental
HAND PIECE FOR BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GZL·May 29, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 22, 2008
CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·June 19, 2011
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·June 1, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
FDA Recall
Terminated
·Plus Orthopedics USA·Product code KTT·February 22, 2006
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015