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
140233–140256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1987
AEROSOL ONE, NEBULIZER PUMP
K870428 · BTI
Ashai Co. , Ltd.
Anesthesiology · 101d
Cleared May 15, 1987
PRECIMAT(R) C3
K871024 · CZW
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
PRECINORM(R) PROTEIN
K871027 · DAF
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared May 15, 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 60d
Cleared May 15, 1987
CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY
K871066 · CAZ
The Kendal Co.
Anesthesiology · 59d
Cleared May 15, 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · KDI
Gambro, Inc.
Gastroenterology & Urology · 57d
Cleared May 15, 1987
THE SPIRA ELEKTRO 2
K871151 · CCQ
Warren E. Collins, Inc.
Anesthesiology · 53d
Cleared May 15, 1987
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
K871193 · JZO
Cronus
Immunology · 52d
Cleared May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · JQP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · CFN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
CELL LIFTER
K871559 · LIB
Corning Costar Corp.
Microbiology · 23d
Cleared May 15, 1987
SPOTTEST FLAGELLA STAIN
K871606 · JTS
Difco Laboratories, Inc.
Pathology · 21d
Cleared May 15, 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · JTN
Organon Teknika Corp.
Microbiology · 16d
Cleared May 15, 1987
EMED-F-SYSTEM
K871690 · IKE
Novel GmbH
Physical Medicine · 16d
Cleared May 15, 1987
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
K871709 · KZJ
Difco Laboratories, Inc.
Microbiology · 14d
Cleared May 15, 1987
DRIPRIDE DISPOSABLE UNDERPADS
K871725 · KME
Weyerhaeuser Co.
General Hospital · 11d
Cleared May 14, 1987
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · BTO
Cook, Inc.
Anesthesiology · 119d
Cleared May 14, 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · DXH
Medtronic Vascular
Cardiovascular · 86d
Cleared May 14, 1987
EFER ARTHROSCOPE
K870654 · HRX
Roseburg SA
Orthopedic · 90d
Cleared May 14, 1987
PENTAMAX 1 MODEL B TABLE SYSTEM
K870707 · IXR
Spectrum X-Ray Corp.
Radiology · 83d
Cleared May 14, 1987
BADGWELL SAMPLING CATHETER
K870858 · CCK
Dryden Corp.
Anesthesiology · 72d
Cleared May 14, 1987
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
K870903 · LRM
Immunomedics, Inc.
Immunology · 70d
Cleared May 14, 1987
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 65d