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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151249–151272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1984
HOLTER SCREENING MONITOR HS-221
K842462 · DRT
Advantage Medical Systems, Inc.
Cardiovascular · 81d
Cleared Sep 11, 1984
BUFFERED SALINE
K842722 · JCE
E K Ind., Inc.
Pathology · 60d
Cleared Sep 11, 1984
FORMALIN-ACETO-ALCOHOL FIXATIVE
K842731 · IGF
E K Ind., Inc.
Pathology · 60d
Cleared Sep 11, 1984
PAP STAIN EA-65
K842735 · HZJ
E K Ind., Inc.
Pathology · 60d
Cleared Sep 11, 1984
PAP STAIN, EA-36
K842739 · HZJ
E K Ind., Inc.
Pathology · 60d
Cleared Sep 11, 1984
STAIN, METHYLENE BLUE-EOSIN
K842785 · KFC
Reagent Laboratory, Inc.
Pathology · 71d
Cleared Sep 11, 1984
DIFFERENTIAL DIAG. OCCLUSAL APPLIANCE
K842788 · JXL
Brimms, Inc.
Neurology · 50d
Cleared Sep 11, 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858 · FPA
Norton Performance Plastics Corp.
General Hospital · 50d
Cleared Sep 11, 1984
SUDAN IV HERXHEIMER
K842916 · KKK
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
SCOTTS TAP WATER SUBSTITUTE
K842918 · JCC
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
SCHIFF REAGENT FUCHSIN-SULFUROUS ACID
K842919 · HZT
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
PICRIC ACID 1% W/V
K842923 · LDW
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
MUCI-CARMINE STAIN, MAYER'S FORMULA
K842925 · HZC
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
METHYLENE BLUE STAIN, LOEFFLER
K842926 · KFC
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
LIGHT GREEN SF 1%
K842927 · HYS
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
JENNER BLOOD STAIN
K842928 · KJX
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
GOMORI'S TRICHROME STAIN
K842930 · LED
E K Ind., Inc.
Pathology · 48d
Cleared Sep 11, 1984
CARBOL-FUCHSIN, ZIEHL-NEEDSEN
K842933 · ICL
E K Ind., Inc.
Pathology · 48d
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