FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

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175,820 results
125281–125304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1990
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
K902335 · JWH
Intermedics Orthopedics
Orthopedic · 90d
Cleared Aug 22, 1990
TRI-COUNT 16
K902389 · JCN
Hematronix, Inc.
Hematology · 84d
Cleared Aug 22, 1990
CELL-DYN 3000 CONTROL
K902391 · JCN
Unipath , Ltd.
Hematology · 84d
Cleared Aug 22, 1990
LYMPHO SEP(TM)
K902445 · JCF
Icn Biomedicals, Inc.
Hematology · 82d
Cleared Aug 22, 1990
FLORA-STAT URINE TRANSPORT SYSTEM
K902467 · LIO
Wadley Biosciences Corp.
Microbiology · 79d
Cleared Aug 22, 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639 · GGT
Incstar Corp.
Hematology · 69d
Cleared Aug 22, 1990
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
K902733 · BTM
Intertech Resources, Inc.
Anesthesiology · 62d
Cleared Aug 22, 1990
PR CANNULAS
K902734 · FGE
Olympus Corp.
Gastroenterology & Urology · 62d
Cleared Aug 22, 1990
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL
K902909 · JJY
Creative Laboratory Products, Inc.
Chemistry · 50d
Cleared Aug 22, 1990
IL PHENYTOIN ASSAY SYSTEM
K902952 · DIP
Instrumentation Laboratory CO
Toxicology · 48d
Cleared Aug 22, 1990
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET
K903101 · DLJ
Innotron of Oregon, Inc.
Toxicology · 40d
Cleared Aug 22, 1990
KODATROL LIQUID CONTROL LEVELS I & II
K903189 · DIF
Eastman Kodak Company
Chemistry · 34d
Cleared Aug 22, 1990
IL TOBRAMYCIN ASSAY
K903192 · KLB
Instrumentation Laboratory CO
Chemistry · 34d
Cleared Aug 22, 1990
REDITEST STREP A TEST KIT
K903194 · GTZ
Boehringer Mannheim Corp.
Microbiology · 34d
Cleared Aug 22, 1990
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 28d
Cleared Aug 22, 1990
MAGNESIUM
K903341 · JGJ
Catachem, Inc.
Chemistry · 28d
Cleared Aug 22, 1990
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · CGI
Immunotech Corp.
Chemistry · 28d
Cleared Aug 22, 1990
GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L
K903402 · GXY
Medi-Source, Inc.
Neurology · 22d
Cleared Aug 22, 1990
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Aug 21, 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K896075 · FRN
Pharmacia Deltec, Inc.
General Hospital · 306d
Cleared Aug 21, 1990
AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM
K896356 · IYO
Esaote Biomedica Spa
Radiology · 288d
Cleared Aug 21, 1990
ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500
K896644 · ITX
Shimadzu Corp.
Radiology · 270d
Cleared Aug 21, 1990
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
K897073 · ITX
Shimadzu Corp.
Radiology · 242d
Cleared Aug 21, 1990
INFUSION PUMP
K901065 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 167d