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
152233–152256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1984
OPTIMATE IGM TEST
K841814 · DFT
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
OPTIMATE IGG TEST
K841816 · DEW
Miles Laboratories, Inc.
Immunology · 52d
Cleared Jun 22, 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · JHI
Travenol Laboratories, S.A.
Chemistry · 51d
Cleared Jun 22, 1984
PREG-BETA ONE HOUR TUBE TEST
K841853 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 50d
Cleared Jun 22, 1984
BHCG RIA
K841854 · JHI
Syncor Intl. Corp.
Chemistry · 50d
Cleared Jun 22, 1984
HEART-CHECK ECG TRANSMITTER
K841875
Physio Ventures, Inc.
Cardiovascular · 46d
Cleared Jun 22, 1984
PARAMAX IRON REAGENT
K841886 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
PARAMAX IRON BLANK REAGENT
K841887 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
ABBOTT PROJECT I
K841916 · JJE
Abbott Laboratories
Chemistry · 44d
Cleared Jun 22, 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
HANKS BALANCED SALTS-HBSS H2387
K842002 · KIT
Sigma Chemical Co.
Pathology · 37d
Cleared Jun 22, 1984
CHLORIDE TEST KIT
K842011 · CHJ
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Jun 22, 1984
TIBC PRETREATMENT KIT
K842019 · JQE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025 · JGS
Hi Chem, Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ELVI 165 PROTEO SEROSKOP
K842056 · JQT
Logos Scientific, Inc.
Chemistry · 31d
Cleared Jun 22, 1984
ADP ANA IFA TEST
K842183 · DHN
Apple Diagnostic Products
Immunology · 21d
Cleared Jun 22, 1984
PLAIN JANE SERIES WHEELCHAIR
K842232 · IOR
Invacare Corp.
Physical Medicine · 17d
Cleared Jun 22, 1984
SPOT TEST NINHYDRIN REAGENTS
K842290 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
SPOT TEST CATALASE TEST
K842291 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
ISOSTATION LOWER BACK MACHINE
K842296 · IKK
Isotechnologies, Inc.
Physical Medicine · 11d
Cleared Jun 22, 1984
ARGINIE BROTH
K842297 · JSF
Remel Co.
Microbiology · 11d
Cleared Jun 22, 1984
ONPG DISKS
K842300 · JSF
Irvine Diagnostic Services
Microbiology · 11d
Cleared Jun 22, 1984
VITACOMM 100 ESOPHAGEAL STETHOSCOPE
K842309 · BZT
Vitacomm, Inc.
Anesthesiology · 10d