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
150193–150216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 1985
SYVA SAMPLE SEAL
K844949 · KIE
Syva Co.
Toxicology · 57d
Cleared Feb 15, 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · HLI
Nidek, Inc.
Ophthalmic · 53d
Cleared Feb 15, 1985
POLLENEX DIGITAL THERMOMETER T-125
K850362 · FLL
Associated Mills, Inc.
General Hospital · 16d
Cleared Feb 15, 1985
POLLENEX DIGITAL THERMOMETER T-225
K850363 · FLL
Associated Mills, Inc.
General Hospital · 16d
Cleared Feb 15, 1985
QUINTON WHITE SEALING CAP
K850369 · FOZ
Quinton, Inc.
General Hospital · 15d
Cleared Feb 15, 1985
LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-
K850432 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 11d
Cleared Feb 14, 1985
YKI-770 ELECTRONIC SPHYGMOMAMETER
K842318 · DXN
Yukosha Co., Inc.
Cardiovascular · 247d
Cleared Feb 14, 1985
CILCO I/A SURGICAL PACK
K843319 · HQC
Cilco, Inc.
Ophthalmic · 174d
Cleared Feb 14, 1985
KANGAROO NASOGASTRIC FEEDING TUBE
K843567 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 157d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR W/FILTER
K843595 · DTN
Omnis Surgical, Inc.
Cardiovascular · 155d
Cleared Feb 14, 1985
UNIVERSAL-BODYTEST
K843846 · CCM
Erich Jaeger, Inc.
Anesthesiology · 136d
Cleared Feb 14, 1985
BODYSCREEN II
K843851 · CCM
Erich Jaeger, Inc.
Anesthesiology · 136d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · DTN
Gish Biomedical, Inc.
Cardiovascular · 135d
Cleared Feb 14, 1985
PEDIATRIC SIZE K-TUBE A OR B
K843939 · KNT
Midwest Metabolic Support Group
Gastroenterology & Urology · 128d
Cleared Feb 14, 1985
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Feb 14, 1985
BILIARY STENT PROSTHESIS
K844384 · FGE
Mentor Corp.
Gastroenterology & Urology · 93d
Cleared Feb 14, 1985
DTL ELECTRODE
K844409 · HLZ
Sauquoit Industries, Inc.
Ophthalmic · 92d
Cleared Feb 14, 1985
PHARMACIA B2-MICRO EIA
K844469 · JZG
Pharmacia, Inc.
Microbiology · 87d
Cleared Feb 14, 1985
SIEGEN VISUAL STIMULATOR
K844616 · GWE
Siegen Corp.
Neurology · 79d
Cleared Feb 14, 1985
FRESENIUS HAEMODIALYSIS
K844641 · FKQ
Seratronics, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 14, 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · DTD
Pacesetter Systems
Cardiovascular · 62d
Cleared Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · DSH
Spacelabs, Inc.
Cardiovascular · 56d
Cleared Feb 14, 1985
AVA-MIST PORTABLE AIR COMPRESSOR
K844956 · BTI
Avatron, Inc.
Anesthesiology · 55d
Cleared Feb 14, 1985
SPIROMETRICS 2453 & SMI III
K850045 · BTY
Spirometrics, Inc.
Anesthesiology · 38d