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
154849–154872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1984
OCULASE 514 OPHTHALMIC ARGON LASER
K833532 · HQF
Lasermed Corp.
Ophthalmic · 116d
Cleared Feb 04, 1984
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · DTR
Shiley, Inc.
Cardiovascular · 110d
Cleared Feb 04, 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · DYG
Instrumentation Laboratory CO
Cardiovascular · 81d
Cleared Feb 04, 1984
T3 RIA
K833853 · CDP
Syncor Intl. Corp.
Chemistry · 92d
Cleared Feb 04, 1984
C-LOOPS
K833856
Concept, Inc.
General & Plastic Surgery · 89d
Cleared Feb 04, 1984
SAV-A-LIMB
K833872 · KYR
Sil-Med Corp.
General Hospital · 88d
Cleared Feb 04, 1984
IRRI-CATH
K833908 · BSY
Portex, Inc.
Anesthesiology · 82d
Cleared Feb 04, 1984
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 82d
Cleared Feb 04, 1984
SUPERIOR ENTERNAL FEEDING SYSTEM
K833947 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 81d
Cleared Feb 04, 1984
VANISH
K833976 · KGO
Parke-Davis Co.
General Hospital · 79d
Cleared Feb 04, 1984
PROTOPATH FACTOR IX ASSAY
K834050 · GGP
American Dade
Hematology · 73d
Cleared Feb 04, 1984
PROTOPATH FACTOR VIII ASSAY
K834051 · GGP
American Dade
Hematology · 73d
Cleared Feb 04, 1984
DART ALPHA-AMYLASE REAGENT SYSTEM
K834053 · CIJ
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Feb 04, 1984
DART GAMMA-GT REAGENT SYSTEM
K834054 · JQB
Coulter Electronics, Inc.
Chemistry · 73d
Cleared Feb 04, 1984
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057 · KLK
Instrumentation Laboratory CO
Anesthesiology · 73d
Cleared Feb 04, 1984
RELIANCE OPHTHALMIC SLIT LAMP R-083
K834060 · HQF
F. & F. Koenigkramer
Ophthalmic · 71d
Cleared Feb 04, 1984
STERILE LABELS
K834062 · LDQ
Devon Industries, Inc.
General & Plastic Surgery · 71d
Cleared Feb 04, 1984
MATCHED COMPONENT SET FOR DIGITOXIN
K834080 · LCW
Cambridge Medical Technology
Toxicology · 68d
Cleared Feb 04, 1984
HYDROXYBUTYRATE DEHYDROGENASE REAGENT
K834084 · JKF
Sterling Biochemical, Inc.
Chemistry · 68d
Cleared Feb 04, 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · DQY
Quinton, Inc.
Cardiovascular · 67d
Cleared Feb 04, 1984
ANTENSE ANTI-TENSION DEVICE
K834110 · HCC
Bio Sig Instruments, Inc.
Neurology · 67d
Cleared Feb 04, 1984
PHASE II CORTISOL KIT
K834219 · CGR
Medical & Scientific Designs, Inc.
Chemistry · 61d
Cleared Feb 04, 1984
GRADUATED GUIDE WIRE BOWL 8
K834237 · DQX
Sterile Design, Inc.
Cardiovascular · 60d
Cleared Feb 04, 1984
PROGESTERONE TEST SET 125I 17-OH
K834246 · JLX
Wien Laboratories, Inc.
Chemistry · 59d