FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96889–96912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1996
KERR ADVANCED ADHESIVE
K962515 · KLE
Kerr Dental Materials Center
Dental · 35d
Cleared Aug 01, 1996
GENERAL PURPOSE DENTAL TRAY
K962527 · EIA
Medcare Medical Group, Inc.
Dental · 35d
Cleared Aug 01, 1996
UROSURGE ACUTRAINER
K962770 · KPN
Princeton Regulatory Assoc.
Gastroenterology & Urology · 16d
Cleared Aug 01, 1996
OSTEOGRAF STAINLESS STEEL SYRING
K962786 · LYC
Ceramed Corp.
Dental · 15d
Cleared Jul 31, 1996
LOOP/SQUARE ELECTRODE
K952030 · HGI
E & M Engineering, Inc.
Obstetrics & Gynecology · 457d
Cleared Jul 31, 1996
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · KPF
Fresenius USA, Inc.
Gastroenterology & Urology · 226d
Cleared Jul 31, 1996
C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM
K960006 · CAC
Fresenius AG
Anesthesiology · 211d
Cleared Jul 31, 1996
SNARE
K960230 · FDI
Lighthouse Medical, Inc.
Gastroenterology & Urology · 196d
Cleared Jul 31, 1996
SPHINCTEROTOME
K960231 · KNS
Lighthouse Medical, Inc.
Gastroenterology & Urology · 196d
Cleared Jul 31, 1996
NORTHEAST MONITORING DR180
K960925 · DSH
North East Monitoring, Inc.
Cardiovascular · 147d
Cleared Jul 31, 1996
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K961014 · LOS
Quinton, Inc.
Cardiovascular · 140d
Cleared Jul 31, 1996
BALLON DILATATION CATHETER
K961438 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jul 31, 1996
INFINET
K961689 · LMD
Infimed, Inc.
Radiology · 91d
Cleared Jul 31, 1996
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104...
K961706 · LKN
Fresenius USA, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 31, 1996
ACTA
K961735 · EBZ
Satelec
Dental · 89d
Cleared Jul 31, 1996
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
K961777 · DQX
Cardio Metrics, Inc.
Cardiovascular · 85d
Cleared Jul 31, 1996
PRECLUDE SYNBLOC MEMBRANE
K961802 · GXO
W.L. Gore & Associates, Inc.
Neurology · 83d
Cleared Jul 31, 1996
FLOUROSPOT T.O.P.
K961871 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Jul 31, 1996
KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
K961977 · CBI
Kendall Healthcare Products Co....
Anesthesiology · 72d
Cleared Jul 31, 1996
HUMIDIFIER ADAPTER
K962079 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 64d
Cleared Jul 31, 1996
ORIGEN ANALYZER
K962166 · JJQ
Igen, Inc.
Chemistry · 57d
Cleared Jul 31, 1996
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
K962273 · MFD
Marlo Surgical Technology
Obstetrics & Gynecology · 48d
Cleared Jul 31, 1996
TENS/FES/NMES ELECTRODES
K962332 · GZJ
Uni-Patch, Inc.
Neurology · 44d
Cleared Jul 31, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387 · FFL
Olympus America, Inc.
Gastroenterology & Urology · 41d