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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
153025–153048 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1984
PENLON ANESTHESIA VENTILATOR SERIES 300
K842363 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 11d
Cleared Jun 26, 1984
SPIROMATE AS-500
K842372 · BZG
Riko Medical & Scientific Instrument...
Anesthesiology · 11d
Cleared Jun 26, 1984
AVATRON DISPOSABLE I.P.P.B. CIRUCIT
K842389 · BZO
Avatron, Inc.
Anesthesiology · 8d
Cleared Jun 26, 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 7d
Cleared Jun 25, 1984
LYRIS MODULAR INFO SYSTEM
K831830 · JQP
Biovation, Inc.
Chemistry · 384d
Cleared Jun 25, 1984
ULTRAMAX
K832705 · LIF
Medicorp, Inc.
Gastroenterology & Urology · 318d
Cleared Jun 25, 1984
VITAMIN B12 57CO/FOLATE 125I -
K840462 · CDD
Corning Medical & Scientific
Chemistry · 144d
Cleared Jun 25, 1984
SRC TOTAL KNEE
K841022
Joint Medical Products Corp.
Orthopedic · 105d
Cleared Jun 25, 1984
PULSE GENERATOR 698, 698B & 698L
K841229 · DXY
Siemens Elema AB
Cardiovascular · 95d
Cleared Jun 25, 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · KWL
Biomet, Inc.
Orthopedic · 80d
Cleared Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526 · GQX
Ortho Diagnostic Systems, Inc.
Microbiology · 74d
Cleared Jun 25, 1984
DOUBLE LUMEN SUBLCAVIAN-FEMORAL
K841530 · KNZ
Medical Components, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 25, 1984
NEOS M
K841636 · DXY
Biotronik Sales, Inc.
Cardiovascular · 67d
Cleared Jun 25, 1984
T3 UPTAKE
K841927 · KHQ
Syncor Intl. Corp.
Chemistry · 46d
Cleared Jun 25, 1984
ENZYMATIC ACETAMINOPHEN ASSAY
K841930 · LKP
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 46d
Cleared Jun 25, 1984
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
K841947 · CHP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
TESTOSTERONE DIRECT RADIOIMMUNOASSAY
K841948 · CDZ
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
PULSE GENERATOR KALOS-04
K841950 · DXY
Biotronik Sales, Inc.
Cardiovascular · 52d
Cleared Jun 25, 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 42d
Cleared Jun 25, 1984
GASTRIN RIA
K841963 · CGC
Syncor Intl. Corp.
Chemistry · 42d
Cleared Jun 25, 1984
HL-1, DEFINED SERUM FREE MEDIA
K841993 · KIT
Ventrex Laboratories, Inc.
Microbiology · 41d
Cleared Jun 25, 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · CEE
Nichols Institute Diagnostics
Chemistry · 39d
Cleared Jun 25, 1984
SIGMA PROCEDURE 47-UV
K842013 · CGS
Sigma Chemical Co.
Chemistry · 39d
Cleared Jun 25, 1984
BX-400
K842142 · IPF
Bloomex International, Inc.
Physical Medicine · 26d