FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12769–12792 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · JMK
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
K772034
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035 · JFJ
Harleco
Chemistry · 21d
Cleared Nov 15, 1977
TELETHERMOMETER MODEL T T-400
K771997 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
TEMP-A-LERT MODEL TA-986
K771998 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
ELECTROTHERM MODELS F&C18,14,78, F84
K771999 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028 · CFJ
Harleco
Chemistry · 19d
Cleared Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029 · CIT
Harleco
Chemistry · 19d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927 · JMO
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928 · CJY
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · CKA
Harleco
Chemistry · 18d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
K772031
Harleco
Chemistry · 18d
Cleared Nov 11, 1977
TMA BICARBONATE/GLYCEROL DILUENT
K771700
Hyland Therapeutic Div., Travenol...
Chemistry · 65d
Cleared Nov 11, 1977
FASTCHEM BUN
K771923 · CDQ
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · CEK
Harleco
Chemistry · 28d
Cleared Nov 11, 1977
SPECTROPHOTOMETER CARY 219
K772022 · JJQ
Varian Assoc., Inc.
Chemistry · 16d
Cleared Nov 11, 1977
URIC ACID STD. FOR QUANT. URIC ACID
K772025 · JIS
Worthington Biochemical Corp.
Chemistry · 15d
Cleared Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · GKL
Coulter Electronics, Inc.
Chemistry · 93d
Cleared Nov 07, 1977
STAC SYSTEM
K771821 · JJF
Technicon Instruments Corp.
Chemistry · 45d
Cleared Nov 03, 1977
DYNAZYME II GPT 340
K771152 · CKA
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Nov 03, 1977
DYNA ZYME II GOT 340
K771153 · CIT
J.T. Baker Chemical Co.
Chemistry · 129d
Cleared Nov 03, 1977
AMIDO BLACK CONCENTRATE
K771720 · CEF
Sigma Chemical Co.
Chemistry · 51d
Cleared Nov 03, 1977
CREATININE
K771834 · CGX
Gamma Enterprises, Inc.
Chemistry · 43d
Cleared Nov 03, 1977
SERUM IRON
K771838 · JIY
Gamma Enterprises, Inc.
Chemistry · 43d