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
152113–152136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1984
GRAM STAIN
K843050 · JTS
Reagent Laboratory, Inc.
Microbiology · 39d
Cleared Sep 11, 1984
ACUFEX ARTHROSCOPE
K843208 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 27d
Cleared Sep 11, 1984
ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD
K843261 · DRE
Angiosystems, Inc.
Cardiovascular · 22d
Cleared Sep 11, 1984
INDOLE SPOT TEST KIT 270-25
K843316 · JTO
Applied Polytechnology, Inc.
Microbiology · 18d
Cleared Sep 10, 1984
PROTOMED/TOWIC NASOGASTRIC TUBE DRAINAGE BAG
K841986 · KNT
Protomed Corp.
Gastroenterology & Urology · 118d
Cleared Sep 10, 1984
OSTOMY OR UROSTOMY ABDOMINAL BELT OS
K842119 · EXB
Atlas Surgical Belt Co., Inc.
Gastroenterology & Urology · 110d
Cleared Sep 10, 1984
FORMACLEAR- & MULTIPLE
K842131 · FKQ
Rna Medical Corp.
Pathology · 103d
Cleared Sep 10, 1984
AIMED FOLEY CATHETER VARIOUS SIZES
K842228 · KOD
Tech-Cons Ltd., Intl.
Gastroenterology & Urology · 97d
Cleared Sep 10, 1984
ELVI 146 SEROSCAN
K842313 · JQT
Logos Scientific, Inc.
Chemistry · 90d
Cleared Sep 10, 1984
URETHRAL CATHETERIZATION TRAY
K842866 · KOD
Inmed Corp.
Gastroenterology & Urology · 49d
Cleared Sep 10, 1984
CURITY SUPRAPUBIC DRAINAGE SYSTEM
K842899 · LJE
The Kendal Co.
Gastroenterology & Urology · 49d
Cleared Sep 09, 1984
SICKLING HEMOGLOBIN CONTROLS, NORMAL
K842152 · GHM
Isolab, Inc.
Hematology · 102d
Cleared Sep 07, 1984
CMV LATEX AGGLUTINATION TEST KIT
K841520 · LJO
Bd Becton Dickinson Vacutainer...
Microbiology · 148d
Cleared Sep 07, 1984
RADIOEAR M430 PP
K841934 · ESD
Radioear Corp.
Ear, Nose, Throat · 119d
Cleared Sep 07, 1984
AMERICAN MEDICAL OPTICS IMAGING SYS
K842127 · IYO
American Medical Optics
Radiology · 101d
Cleared Sep 07, 1984
AMIZYME-TOXOPLASMA GONDII KIT
K842528 · LGD
Amico Lab, Inc.
Microbiology · 71d
Cleared Sep 07, 1984
HOME NUTRIBAG MIXING CONTAINER 1000ML
K842628 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 63d
Cleared Sep 07, 1984
HOME NUTRIBAG MIXING CONTAINER 3000ML
K842629 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 63d
Cleared Sep 07, 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · CGA
Bd Becton Dickinson Vacutainer...
Chemistry · 59d
Cleared Sep 07, 1984
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · KHQ
Terumo Medical Corp.
Chemistry · 58d
Cleared Sep 07, 1984
CARNOY'S SOLUTION
K842737 · IGM
E K Ind., Inc.
Pathology · 56d
Cleared Sep 07, 1984
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 52d
Cleared Sep 07, 1984
CODE-A-WELL 350 MICROTITRATION STRIPS
K842848 · JTC
Plastic Injectors, Inc.
Chemistry · 49d
Cleared Sep 07, 1984
WRIGHT STAIN FIXATIVE
K842913 · LDZ
E K Ind., Inc.
Pathology · 44d