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
145273–145296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 1986
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
K851243 · LJS
Cook, Inc.
General Hospital · 381d
Cleared Mar 14, 1986
HANDI-MOVE
K854461 · ILK
T.F. Herceg, Inc.
Physical Medicine · 128d
Cleared Mar 14, 1986
SOLAR CART
K854642 · EIA
Alpine Dental Equipment Co.
Dental · 115d
Cleared Mar 14, 1986
SOLAR
K854643 · EIA
Alpine Dental Equipment Co.
Dental · 115d
Cleared Mar 14, 1986
PRIMADERM
K854740 · NAD
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 109d
Cleared Mar 14, 1986
UROFLEX
K854908 · FAD
Angiomed U.S., Inc.
Gastroenterology & Urology · 95d
Cleared Mar 14, 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · JIX
Kallestad Laboratories, Inc.
Immunology · 88d
Cleared Mar 14, 1986
KM-3 ACETABULAR COMPONENT
K855042 · JDL
Kirschner Medical Corp.
Orthopedic · 87d
Cleared Mar 14, 1986
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
K855091 · CDS
Sen Tech Medical Corp.
Chemistry · 84d
Cleared Mar 14, 1986
CAT-3 CATECHOLAMINE ASSAY KIT
K855214 · CHQ
Whale Scientific, Inc.
Chemistry · 74d
Cleared Mar 14, 1986
ULTRAMAX III, DIALYZER REPROCESSING DEVICE
K860026 · LIF
Medicorp, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 14, 1986
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K860245 · JFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 49d
Cleared Mar 14, 1986
AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
K860253 · CHO
Amersham Corp.
Chemistry · 49d
Cleared Mar 14, 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478 · JIY
Sterling Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 14, 1986
MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY
K860496 · LNK
Xanar, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 14, 1986
SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
K860554 · CFG
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 14, 1986
ANDROSTENEDIONE 125I KIT BY RIA
K860559 · CIZ
Immuchem Corp.
Chemistry · 28d
Cleared Mar 14, 1986
SYNATOMIC REVISION FEMORAL PROSTHESIS
K860594 · JWH
Depuy, Inc.
Orthopedic · 23d
Cleared Mar 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K860628 · CEO
Sterling Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 14, 1986
OPTI-FIX TOTAL HIP SYSTEM
K860635 · LPH
Richards Medical Co., Inc.
Orthopedic · 22d
Cleared Mar 14, 1986
M.C.R. KNEE PROSTHESIS (SERIES 3000)
K860654 · JWH
Osteonics Corp.
Orthopedic · 21d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS
K860660 · CHS
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · CIX
Amresco, Inc.
Chemistry · 18d
Cleared Mar 14, 1986
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · CHJ
Amresco, Inc.
Chemistry · 18d