18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
GGM Breathing Circuit Bacterial Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039518·DEPTH RULER FOR sEEG DEPTH, FOR ALL DRILL SIZES
OFFSET ACETABULAR
FDA UDI
Biomet Orthopedics, LLC·00880304451117·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319707135·Lewis (Joseph) Rasp 7-1/2" (18.8cm), backward c...
REGENEREX HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304450219·
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK
Resolve® Ceramic
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
STRYKER QUIKFLAP STERILE PROCEDURE PACK
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
ON-Q CATHETER
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code BSO·August 9, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·August 8, 2014
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·July 8, 2013
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C4240J (Reorder No. 21-0352-25) Specialty Administration Set described as 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml and 2 Injection sites and 0.22 micron filter.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015