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
138529–138552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1987
(MEM) EAGLE NO. M3149 W/HANKS' SALTS
K873095 · KIT
Sigma Chemical Co.
Pathology · 19d
Cleared Aug 25, 1987
ABBOTT A-GENT IRON REAGENT KIT
K873120 · CFM
Abbott Laboratories
Chemistry · 15d
Cleared Aug 25, 1987
MANAN TURNER STYLE NEEDLE
K873208 · KNW
Manan Manufacturing Co., Inc.
Gastroenterology & Urology · 11d
Cleared Aug 25, 1987
PLAQUE-SWEEP
K873209 · EFB
Dentsply Intl.
Dental · 11d
Cleared Aug 24, 1987
BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT
K871773 · LYC
Geistlich-Pharma
Dental · 110d
Cleared Aug 24, 1987
CHROMOTITRE E.I.A. RUBELLA IGG
K872071 · LFX
Ismunit Istituto Immunologico Intaliano
Microbiology · 87d
Cleared Aug 24, 1987
OXYGENATOR MODEL NO. BENTLEY 5 PLUS
K872133 · DTZ
American Bentley
Cardiovascular · 83d
Cleared Aug 24, 1987
DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST
K872493 · GTZ
Bd Becton Dickinson Vacutainer...
Microbiology · 62d
Cleared Aug 24, 1987
DEN-MAT TENURE
K872510 · EBF
Den-Mat Corp.
Dental · 61d
Cleared Aug 24, 1987
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K872776 · KWL
Depuy, Inc.
Orthopedic · 41d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR (TSA - PRODUCT #P2802)
K873053 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
MACCONKEY AGAR - PRODUCT #P1606
K873055 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR (TSA) W/SXT - PRODUCT #P2933
K873056 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML
K873057 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810
K873058 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML
K873059 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002
K873060 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405
K873061 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T9172
K873062 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 20d
Cleared Aug 24, 1987
ROUND 1
K873086 · JXA
Bioclinical Systems, Inc.
Microbiology · 18d
Cleared Aug 24, 1987
IN VITRO 2.5X ROLLER BOTTLE
K873137 · KJC
In Vitro Scientific Products
Pathology · 14d
Cleared Aug 21, 1987
EXERSYSTEM(TM) MMC 5000
K864911 · BZM
Med Science
Anesthesiology · 249d
Cleared Aug 21, 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · CIC
Trace Scientific , Ltd.
Chemistry · 205d
Cleared Aug 21, 1987
CHLORIDE REAGENT - THIOCYANATE METHOD
K870367 · CHJ
Trace Scientific , Ltd.
Chemistry · 205d