FDA 501(k) PMN

Database of Premarket Notifications


PMN requirements apply to Class III devices, the most stringent regulatory category for medical devices. The latest PMN approved devices are listed below. Search the PMN database here.

Latest Premarket Notifications

ManufacturerDevice NameDate
Cadwell Bolt Software2019-11-23
DEXIS CariVu 3-in-1 By KaVo2019-11-23
3M™ Attest™ Steam Chemical Integrators2019-11-22
6450 Ultrasound System2019-11-22
ADVIA Centaur CA 15-3 Assay2019-11-22
AMIStem-P Short Neck2019-11-22
Applied Medical Laparoscopic Linear Cutter2019-11-22
BruxZir GT (Gum Tissue) Color2019-11-22
C2 CryoBalloon EndoGrip2019-11-22
Color Liquid, Vita Liquid2019-11-22
EverX Flow2019-11-22
EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP2019-11-22
EXPD 4343P, EXPD 3643P2019-11-22
Hair Growth System2019-11-22
Healy2019-11-22
Hemochron Signature Elite2019-11-22
INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream2019-11-22
KLS Martin Individual Patient Solutions2019-11-22
LEva Pelvic Digital Health System2019-11-22
MatriStem UBM Pericardial Patch2019-11-22
Medsynapse Ris Pacs & Medsynapse VNA2019-11-22
Navigated Anterolateral Disc Prep Instruments2019-11-22
Navina Smart System, Navina Classic System2019-11-22
Parcus Synd-EZ SS2019-11-22
Parkell Desensitizer Gel2019-11-22
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)2019-11-22
Revitalair 430F2019-11-22
Senhance Surgical System2019-11-22
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare2019-11-22
SMR TT Augmented Glenoid System2019-11-22
Spes Medica Subdermal Needle Electrodes2019-11-22
Synergy Platform, Synergy, Infinity, VersaHD2019-11-22
Trevo NXT ProVue Retriever2019-11-22
Trevo Trak 21 Microcatheter2019-11-22
VariAx Foot2019-11-22
Asahi PTCA Guide Wire Asahi SION Series2019-11-21
Axis Plating System2019-11-21
Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories2019-11-21
CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray2019-11-21
Engage™ Partial Knee System2019-11-21
LZI Cotinine II Enzyme Immunoassay2019-11-21
M. Blue Adjustable Shunt System2019-11-21
PG Pro Microcatheter2019-11-21
SAM IO Intraosseous Access System2019-11-21
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool2019-11-21
SOMATOM Go Platform – SOMATOM Go.Now, Go.Up, Go.All, Go.Top, Go.Sim, Go.Open Pro, Scan & GO2019-11-21
Torpedo Gelatin Foam2019-11-21
UPMR 7902019-11-20
Ziehm 80002019-11-20
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior 2019-11-20
FUJIFILM Endoscope Model EC-760Z-V/L2019-11-20
Penumbra LP Coil System2019-11-20
SDS1.2 Dental Implant2019-11-20
SmartLite Pro Modular LED Curing Light2019-11-20
TranS1 AxiaLIF Plus System2019-11-20
3M Comply Hydrogen Peroxide Chemical Indicator2019-11-16
Dornier Ureteral Stent2019-11-15
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High2019-11-15
Pentax Medical Video Duodenoscope ED34-i10T22019-11-15
EM SA Implant System2019-11-15
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit2019-11-15
DRSplus2019-11-15
Arcus Head Fixation Frame2019-11-15
CoolTone2019-11-15
KeyPrint KeySplint Soft2019-11-15
Ophthalmic Yag Laser System YC-2002019-11-15
ROSA Bracket2019-11-15
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments2019-11-15
Gabriel Feeding Tube With Balloon, And EnFit Connector2019-11-15
SmartSPACE Shoulder System2019-11-15
CAPERE Thrombectomy System2019-11-15
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA2019-11-15
Soltus 5002019-11-15
SPY Portable Handheld Imaging (SPY-PHI) System2019-11-15
TDM Plate And Screw Systems2019-11-15
Brainlab Compatible K2M Navigation Instruments2019-11-14
LongBow Ti2019-11-14
E-100 Electrosurgical Generator, SynchroSeal2019-11-14
HeraBEAT™ US2019-11-14
MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL)2019-11-14
ST Internal Implant System2019-11-14
EBA One Nailing System2019-11-14
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes2019-11-14
Allwin Intra Uterine Insemination Catheters (INSEMINA And INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED And CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE And TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLE2019-11-14
Reprocessed ViewFlex™ Xtra ICE Catheter2019-11-14
AMICUS Separator System2019-11-13
AEON-C Stand Alone System2019-11-13
Infrared Thermometer Model MD-H302019-11-13
EchoGo Core2019-11-13
Piper GO-IO Intraosseous Infusion System2019-11-13
Nox Sleep System2019-11-13
GMA 2.0 Pedicle Screw System2019-11-13
NuVasive CoRoent Small Interlock System2019-11-13

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