Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148177–148200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 1985
MANAN SELDINGER NEEDLE
K851833 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
MANAN GWI GUIDE WIRE INTRODUCER
K851834 · DWS
Manan Manufacturing Co., Inc.
Cardiovascular · 76d
Cleared Jul 11, 1985
ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR
K852018
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 64d
Cleared Jul 11, 1985
ESP EMERGENCY CARE KIT
K852095
Emergency Situation Products
General & Plastic Surgery · 58d
Cleared Jul 11, 1985
MEDTRONIC MODEL 5867-1A
K852236 · KFJ
Medtronic Vascular
Cardiovascular · 50d
Cleared Jul 11, 1985
SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA
K852321
Sylvania Lighting Products
General & Plastic Surgery · 42d
Cleared Jul 11, 1985
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
K852375 · LRS
Ferris Mfg. Corp.
General & Plastic Surgery · 37d
Cleared Jul 11, 1985
NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER
K852402 · FZX
North American Instrument Corp.
General & Plastic Surgery · 35d
Cleared Jul 11, 1985
MYELOGRAM PROCEDURE TRAY
K852501
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 29d
Cleared Jul 11, 1985
STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
K852541 · GFI
Storz Instrument Co.
General & Plastic Surgery · 27d
Cleared Jul 11, 1985
WALDMANN F85/100W UV6
K852576 · FTC
Sylvania Lighting Products
General & Plastic Surgery · 23d
Cleared Jul 11, 1985
APOLLO STERILE BLADES
K852661 · GES
Orthofab, Inc.
General & Plastic Surgery · 17d
Cleared Jul 11, 1985
WALDMANN F85/100W UV21
K852684 · FTC
Sylvania Lighting Products
General & Plastic Surgery · 16d
Cleared Jul 10, 1985
FASTUBE NERVE REGENERATION DEVICE
K850785 · JXI
Research Medical, Inc.
Neurology · 134d
Cleared Jul 10, 1985
APO B RIA KIT
K851389 · MSJ
Iso-Tex Diagnostics
Immunology · 92d
Cleared Jul 10, 1985
ANA/LITE-RL TEST SYSTEM
K852230 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
ANA/LITE-HEP-2 TEST SYSTEM
K852231 · LJM
Immuno-Products Industries
Immunology · 49d
Cleared Jul 10, 1985
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · DDB
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Jul 10, 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · DGC
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Jul 09, 1985
MODEL 1000
K844727 · IPF
Verite
Physical Medicine · 217d
Cleared Jul 09, 1985
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 186d
Cleared Jul 09, 1985
CHOLESTEROL TEST SYSTEM
K850390 · CHH
Hans J. Brouwers & Assoc.
Hematology · 158d
Cleared Jul 09, 1985
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
K850567 · LGD
Abbott Laboratories
Microbiology · 147d
Cleared Jul 09, 1985
CHEM PRO 1000 CHEMISTRY ANALYSIS
K851100 · CEM
Sen Tech Medical Corp.
Chemistry · 112d