Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143305–143328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
K861697 · LCP
Awareness Technology, Inc.
Hematology · 106d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966 · LJC
Boots-Celltech Diagnostics, Inc.
Microbiology · 91d
Cleared Aug 19, 1986
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · DIF
Bio-Rad
Toxicology · 90d
Cleared Aug 19, 1986
ENZYMUN-TEST HCG
K862108 · DHA
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Aug 19, 1986
DEKNA BAND KIT
K862115 · ITG
Deknatel, Inc.
Physical Medicine · 77d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · CZP
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
DAKO ITA, IMMUNOGLOBULIN M (IGM)
K862184 · DAH
Dako Corp.
Immunology · 71d
Cleared Aug 19, 1986
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
K862227 · HHR
Hgm, Inc.
Obstetrics & Gynecology · 69d
Cleared Aug 19, 1986
MAPLE ALLERGEN DISC
K862266 · DHB
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 19, 1986
MODIFICATION OF TISSUE DILATOR
K862288 · DRE
Quinton, Inc.
Cardiovascular · 64d
Cleared Aug 19, 1986
KING DIAGNOSTICS LDH TEST
K862306 · CFJ
King Diagnostics, Inc.
Chemistry · 63d
Cleared Aug 19, 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · LJP
Difco Laboratories, Inc.
Microbiology · 62d
Cleared Aug 19, 1986
TRANS-PULSE MODEL #1103
K862355 · GZJ
The Sun Co.
Neurology · 57d
Cleared Aug 19, 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · DTN
3M Health Care, Sarns
Cardiovascular · 57d
Cleared Aug 19, 1986
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Aug 19, 1986
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
K862364 · HEM
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 19, 1986
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · JLW
American Dade
Chemistry · 54d
Cleared Aug 19, 1986
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K862439 · CGJ
Boots-Celltech Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 53d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 19, 1986
SERACON(TM) CAL (PRODUCT NO. DO35)
K862594 · JIX
Bhp Diagnostix, Inc.
Chemistry · 42d
Cleared Aug 19, 1986
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · CHP
Diagnostic Products Corp.
Chemistry · 42d
Cleared Aug 19, 1986
SERATEST ENA [SS-B] KIT
K862700 · LLL
Hemagen Diagnostics, Inc.
Immunology · 35d
Cleared Aug 19, 1986
SURESPOT
K862701 · JQW
Helena Laboratories
Chemistry · 35d