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
151201–151224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1984
TECHNICON RA-1000 SYS IRON FOR SERUM
K843255 · JIY
Technicon Instruments Corp.
Chemistry · 25d
Cleared Sep 14, 1984
T.I.M.E. DISPENSER
K843272 · JTC
Dynatech Laboratories, Inc.
Microbiology · 25d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ALKALINE PHOSPHATASE REAGENT SET
K843332 · CJE
Sterling Biochemical, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ETHYL ALCOHOL ASSAY KIT
K843378 · DMT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 17d
Cleared Sep 14, 1984
CORNING HIGH RESOLUTION PROTEIN ELECTRO
K843397 · CEF
Corning Medical & Scientific
Chemistry · 16d
Cleared Sep 14, 1984
EMIT 700 BARBITURATE ASSAY
K843418 · DIS
Syva Co.
Toxicology · 14d
Cleared Sep 14, 1984
GRAM STAIN SET W/STABILIZED IODINE
K843429 · JTS
Accra Laboratories, Inc.
Pathology · 10d
Cleared Sep 13, 1984
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · BSY
Research Medical, Inc.
Anesthesiology · 160d
Cleared Sep 13, 1984
AXIOM STABLE II TRIGLYCERIDES TEST
K842443 · CDT
Axiom, Inc.
Chemistry · 84d
Cleared Sep 13, 1984
INFANT APNEA BED STIMULATOR AA-010
K842607
Alpha Medical Systems
General Hospital · 70d
Cleared Sep 13, 1984
DEKA SOLUTION ADMIN. SET DK 302-A
K843054 · FPA
Deka Research & Development Corp.
General Hospital · 41d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112 · JIT
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Sep 13, 1984
ID ZINE LD ISOENZYME CONTROL ABNORM
K843265 · JJT
Beckman Instruments, Inc.
Microbiology · 24d
Cleared Sep 13, 1984
ID ZONE NORMAL LD ISOENZYME CONTROL
K843266 · JJT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
ELVI 675 DIGITRON
K843296 · JJQ
Logos Scientific, Inc.
Chemistry · 23d
Cleared Sep 13, 1984
SYSTEMATE URIC ACID, HEM 67220
K843325 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 13, 1984
CENTURIAN HYDRAULIC STRETCHER
K843439 · FPO
American Sterilizer Co.
General Hospital · 9d
Cleared Sep 12, 1984
CAPILLARY FLOW DIALYZERS
K840937 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 191d