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
149041–149064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1985
FACIAL/UPPER BODY UNIT
K851859 · FTC
Tannhut
General & Plastic Surgery · 18d
Cleared May 13, 1985
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
K850009 · BSO
Vas-Cath of Canada , Ltd.
Anesthesiology · 131d
Cleared May 13, 1985
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171 · GKL
Toa Medical Electronics USA, Inc.
Hematology · 117d
Cleared May 13, 1985
PLATELET AGGREGATION REAGENT
K850592 · JBX
Chrono-Log Corp.
Hematology · 87d
Cleared May 13, 1985
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
K850755 · JPK
R&D Systems, Inc.
Hematology · 77d
Cleared May 13, 1985
UVP 2000 VOLUMED -TENTATIVE
K850997 · FRN
Sterling Medical Devices, Inc.
General Hospital · 63d
Cleared May 13, 1985
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
K851001 · CCK
Marquette Electronics, Inc.
Anesthesiology · 62d
Cleared May 13, 1985
ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18
K851154 · JQT
Astral Medical Systems
Chemistry · 52d
Cleared May 13, 1985
HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT
K851259 · CFL
Nichols Institute Diagnostics
Chemistry · 46d
Cleared May 13, 1985
PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD
K851591 · JSJ
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
SABOURAUD DEXTROSE AGAR
K851592 · JSJ
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
SELECTIVE STREPTOCOCCUS AGAR
K851593 · JSJ
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
SIMMONS CITRATE AGAR
K851595 · JSH
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
SIM MEDIUM
K851596 · JSH
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
TRIPLE SUGAR IRON AGAR
K851597 · JSH
Preferred Micro-Media
Microbiology · 27d
Cleared May 13, 1985
CLINALYZER MODEL VX-1000
K851638 · JJE
Alpkem Corp.
Chemistry · 24d
Cleared May 13, 1985
MEDICAL EXAMINATION LIGHTS
K851742 · KZF
Burton Medical Products Corp.
General Hospital · 14d
Cleared May 13, 1985
FORTEC MI-305
K851873 · FLL
Nam Tai , Ltd.
General Hospital · 14d
Cleared May 10, 1985
PRE-OPERATIVE OPHTHALMIC DRESSING TRAY
K842601 · HOZ
Ophthalmic Resources, Inc.
Ophthalmic · 309d
Cleared May 10, 1985
MINI-HALO CO2 LASER SYSTEM
K843915 · GEX
CooperVision, Inc.
General & Plastic Surgery · 218d
Cleared May 10, 1985
S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS
K844643 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 163d
Cleared May 10, 1985
SURGICAL LASER MICRO-TIPS
K844644 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 163d
Cleared May 10, 1985
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · LCJ
Mentor Corp.
General & Plastic Surgery · 150d
Cleared May 10, 1985
SURGICAL POWER MAGNET
K845029 · FTC
Friedman Labs, Inc.
General & Plastic Surgery · 134d