89 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814688·GENUMEDI SILVER SIZE V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635594·CoRoent Ant TLIF PEEK, 10x12x30mm 15°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814565·GENUMEDI SAND SIZE V
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009496·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...
ILIZAROV SYSTEMS
FDA UDI
MEDICALPLASTIC SRL·28033201841826·THREADED ROD 200MM LENGTH
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780179030·Integra® Jarit® Lillehei-Potts Scissors, 9", Ja...
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 13, 2019
Vasomedical-Biox™ Model 2305 3 CH/ABP COMB Recorder w/Bluetooth
FDA UDI
VASOMEDICAL, INC.·00817980020535·Model 2305 3 CH/ABP COMB Recorder w/Bluetooth
Vasomedical-Biox™ 2305 Combined 3 CH ECG Holter & ABP Monitor with Bluetooth
FDA UDI
VASOMEDICAL, INC.·00817980020115·3 CH ECG Holter/ABP COMB Recorder w/Bluetooth
ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857517127·Cranial Caudal Blade, Size 120 mm
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 30, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
RASCAL
FDA Adverse Event
Malfunction
·ELECTRIC MOBILITY CORP.·Product code INI·May 16, 2011
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
FDA Enforcement
Class III
·Terminated·Microbiologics Inc·February 23, 2022
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
FDA Recall
Terminated
·Microbiologics Inc·Product code JTR·March 25, 2013
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, 2M8163, 2M8163R
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·March 15, 2005