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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
166801–166824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 1980
TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA
K801847 · JSH
Radiation Technology, Inc.
Microbiology · 9d
Cleared Aug 13, 1980
PARALLEL-A-PREP
K801853 · EGI
C.D. Charles, Inc.
Dental · 9d
Cleared Aug 13, 1980
CYCLOPAC TENS
K801855 · GZT
Dow Corning Wright
Neurology · 9d
Cleared Aug 13, 1980
OXYMETER & TRANSOXODE
K801858 · KLH
Thoracel
Microbiology · 9d
Cleared Aug 12, 1980
INPERSOL CAPD ADMIN. SET & CATHETER ADAP
K800993 · KDJ
Abbott Laboratories
Gastroenterology & Urology · 109d
Cleared Aug 12, 1980
CLIRANS TE10 HOLLOW FIBER DIALYZER
K801192 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
CLIRANS TE15 HOLLOW FIBER DIALYZER
K801193 · KDJ
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
CLIRANS TE07 HOLLOW FIBER DIALYZER
K801194 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 12, 1980
PERITONEAL DIALYSIS CYCLER SET W/PUMP
K801220 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 12, 1980
SILICAP
K801227 · EMA
Vivadent (Usa), Inc.
Dental · 81d
Cleared Aug 12, 1980
ACCU-PAP T ZONE SAMPLER
K801238 · HFC
Robert Hasselbrack, M.D.
Obstetrics & Gynecology · 77d
Cleared Aug 12, 1980
NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA
K801346 · GIF
Nobel Scientific Industries, Inc.
Hematology · 64d
Cleared Aug 12, 1980
PAN-AM MYELOGRAM TRAY
K801431 · FMI
Waters Assoc., Inc.
Radiology · 55d
Cleared Aug 12, 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · FRN
Abbott Laboratories
General Hospital · 53d
Cleared Aug 12, 1980
FRAZIER-FERGUSON SUCTION TUBES
K801468 · KCB
Edward Weck, Inc.
Ear, Nose, Throat · 49d
Cleared Aug 12, 1980
HOLLISTER DRAINAGE POUCH
K801504 · FON
Hollister, Inc.
Gastroenterology & Urology · 46d
Cleared Aug 12, 1980
MCGRAW I.V. ADMINISTRATION SET
K801540 · FPA
American Hospital Supply Corp.
General Hospital · 40d
Cleared Aug 12, 1980
GLYCOSYLATED HEMOGLOBIN KIT
K801561 · LCP
Amersham Corp.
Hematology · 35d
Cleared Aug 12, 1980
BIMECO FILTERED EXTENSION SET
K801605 · FPB
Burron Medical Products, Inc.
General Hospital · 28d
Cleared Aug 12, 1980
MCCULLEY CONTINUOUS SUTURE TIGHTNER
K801608 · HND
Edward Weck, Inc.
Ophthalmic · 28d
Cleared Aug 12, 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
K801613 · FPA
Y
General Hospital · 28d
Cleared Aug 12, 1980
COVER-ALL MALE INCONTINENCE DEVICE
K801629 · KNX
The Urology Group
Gastroenterology & Urology · 28d
Cleared Aug 08, 1980
NSI WASH SOLUTION CONCENTRATE
K800587 · JJC
Nobel Scientific Industries, Inc.
Chemistry · 144d
Cleared Aug 07, 1980
MODEL H 607-.67M2 30 MICRON RP AN69 MEM
K800536 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 150d