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
152449–152472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1984
KYOTEST 2V, URINE TEST REAGENT STRIP
K841714 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
KYOTEST UK URINE TEST REAGENT STRIP
K841715 · JIN
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
SALMONELLA-SHIGELLA AGAR
K841746 · JSJ
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
SHEEP BLOOD AGAR
K841748 · KZI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
CHOCOLATE AGAR
K841749 · KZI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
MARTIN-LEWIS AGAR
K841750 · JTY
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
LEVINE EOSIN METHYLENE BLUE AGAR
K841751 · JSI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
K841799 · GIF
Reagent Laboratory, Inc.
Hematology · 43d
Cleared May 31, 1984
LYSING & HEMOGLOBIN REAGENT
K841800 · GGK
Reagent Laboratory, Inc.
Hematology · 43d
Cleared May 31, 1984
ELVI 70 SAFETY CHAMBER
K841804 · JJN
Logos Scientific, Inc.
Chemistry · 30d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MED. MACCONKEY AGAR
K841842 · JSI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MED. LEVINE EMB
K841843 · JSH
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR
K841844 · JSI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
SELECTIVE CULTURE MED. COLUMBIA CNA
K841845 · JSJ
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
RETIC-SET
K841848 · KQC
R&D Systems, Inc.
Hematology · 64d
Cleared May 31, 1984
INNOFLOUR GENTAMICIN
K841865 · LCQ
Innotron Diagnostics
Toxicology · 27d
Cleared May 31, 1984
INNOFLOUR TOBRAMYCIN
K841866 · LFW
Innotron Diagnostics
Toxicology · 27d
Cleared May 31, 1984
MEGA PULSE THERAPY UNIT
K841874 · IMJ
Physio Technology, Inc.
Physical Medicine · 24d
Cleared May 31, 1984
MULTI-PURPOSE TASK SUPPORT TABLE
K841952
Neutral Pos-Chair Co.
General & Plastic Surgery · 17d
Cleared May 30, 1984
MICROMAT W/VARIOUS MODELS
K831117 · FNW
Pmt, Inc.
General Hospital · 421d
Cleared May 30, 1984
TRANSTHORACIC/TRANSABDOMINAL-TRAY
K833720 · GDM
Applied Medical Devices, Inc.
General & Plastic Surgery · 219d
Cleared May 30, 1984
BENZETHONIUM CHLORIDE
K833903 · HPX
Blairex Laboratories, Inc.
Ophthalmic · 198d
Cleared May 30, 1984
INTRAVENOUS INFUSION CONTROLLER
K834106 · LDR
Cutter Laboratories, Inc.
General Hospital · 183d
Cleared May 30, 1984
SUTURE REMOVAL WOUND CLOSURE-INSTRU-
K834367 · HTD
Sterling Multi-Products, Inc.
General & Plastic Surgery · 173d