13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HydroPICC 5F Dual Lumen Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Mini Twin
FDA UDI
Rmo, Inc.·00885797692207·STD EDG MINILP 022 W/O HK 5-5 20EA
OsteoMed
FDA UDI
OSTEOMED LLC·00845694020442·FPS 3.5mm x 50mm Standard Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694074605·FPS 3.5 x 50mm Screw Sterile Qty 2
CLIRANS E-SERIES DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VANGUARD COMPLETE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 11, 2009
TINBN VANGUARD INT PS ANAT FM R 65MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·March 7, 2025
ARTISAN
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 10, 2018
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011
32MM COCR MOD HD +6MM NO SKIRT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 30, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm Acutrak¿ 4/5 Bone Screw AM-0050-S 50.0mm Acutrak¿ 4/5 Bone Screw AP-67100-S 100mm Acutrak¿ 6/7 Fixation Screw AP-67105-S 105mm Acutrak¿ 6/7 Fixation Screw AP-67110-S 110mm Acutrak¿ 6/7 Fixation Screw AP-67115-S 115mm Acutrak¿ 6/7 Fixation Screw AP-67120-S 120mm Acutrak¿ 6/7 Fixation Screw AP-6740-S 40mm Acutrak¿ 6/7 Fixation Screw AP-6745-S 45mm Acutrak¿ 6/7 Fixation Screw AP-6750-S 50mm Acutrak¿ 6/7 Fixation Screw AP-6755-S 55mm Acutrak¿ 6/7 Fixation Screw AP-6760-S 60mm Acutrak¿ 6/7 Fixation Screw AP-6765-S 65mm Acutrak¿ 6/7 Fixation Screw AP-6770-S 70mm Acutrak¿ 6/7 Fixation Screw AP-6775-S 75mm Acutrak¿ 6/7 Fixation Screw AP-6780-S 80mm Acutrak¿ 6/7 Fixation Screw AP-6785-S 85mm Acutrak¿ 6/7 Fixation Screw AP-6790-S 90mm Acutrak¿ 6/7 Fixation Screw AP-6795-S 95mm Acutrak¿ 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak¿ Fusion Device ATF-160-S 16.0mm Acutrak¿ Fusion Device ATF-180-S 18.0mm Acutrak¿ Fusion Device ATF-200-S 20.0mm Acutrak¿ Fusion Device ATF-220-S 22.0mm Acutrak¿ Fusion Device ATF-240-S 24.0mm Acutrak¿ Fusion Device ATF-270-S 27.0mm Acutrak¿ Fusion Device ATF-320-S 32.0mm Acutrak¿ Fusion Device ATF-370-S 37.0mm Acutrak¿ Fusion Device ATM-100-S 10.0mm Mini Acutrak¿ Fixation Screw ATM-120-S 12.0mm Mini Acutrak¿ Fixation Screw ATM-140-S 14.0mm Mini Acutrak¿ Fixation Screw ATM-160-S 16.0mm Mini Acutrak¿ Fixation Screw ATM-180-S 18.0mm Mini Acutrak¿ Fixation Screw ATM-200-S 20.0mm Mini Acutrak¿ Fixation Screw ATM-220-S 22.0mm Mini Acutrak¿ Fixation Screw ATM-240-S 24.0mm Mini Acutrak¿ Fixation Screw ATM-260-S 26.0mm Mini Acutrak¿ Fixation Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023