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
173617–173640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1977
AGGLUTINATING SERUM W135
K771562 · GTJ
Burroughs Wellcome Co.
Immunology · 10d
Cleared Aug 25, 1977
MOBILE X-RAY SYS. MODEL 43820A
K771571 · IZL
Hewlett-Packard Co.
Radiology · 10d
Cleared Aug 25, 1977
PLATELET CONTROLS NORMAL & ABNORMAL
K771588 · GJP
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 7d
Cleared Aug 25, 1977
HEARING AID MODEL 775
K771607 · ESD
Danavox, Inc.
Ear, Nose, Throat · 3d
Cleared Aug 22, 1977
FURNACE AUTOSAMPLER, MODEL 155
K770994 · DOP
Instrumentation Laboratory CO
Toxicology · 82d
Cleared Aug 22, 1977
FORMALIN BUFFER CONCENTRATE
K771201 · IGG
Central Labs. Assoc. MD Pathologists
Pathology · 48d
Cleared Aug 22, 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · CIX
Hycel, Inc.
Chemistry · 42d
Cleared Aug 22, 1977
FLAME PHOTOMETER MODEL 460
K771303 · JIH
Corning Medical & Scientific
Chemistry · 38d
Cleared Aug 22, 1977
TISSUE-TEK III V.I.P.
K771308 · IEO
Miles Laboratories, Inc.
Pathology · 35d
Cleared Aug 22, 1977
CI-TROL COAGULATION CONTROLS II & III
K771346 · GGN
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 33d
Cleared Aug 22, 1977
ALLERGIST PACK SYRINGES
K771359 · FMF
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 28d
Cleared Aug 22, 1977
FLU VEN 0150
K771362 · FPA
Venospital, Inc.
General Hospital · 35d
Cleared Aug 22, 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · CFR
Technicon Instruments Corp.
Chemistry · 26d
Cleared Aug 22, 1977
MONITORING LINES & FLUID ADMIN.
K771387 · FPK
Norton Performance Plastics Corp.
General Hospital · 26d
Cleared Aug 22, 1977
HISTOCHEMICAL AFB DEMONSTRATION
K771390 · ICL
Harleco
Pathology · 26d
Cleared Aug 22, 1977
MONOSTICON TEST
K771397 · KTN
Organon, Inc.
Immunology · 24d
Cleared Aug 22, 1977
IMPREGNATED DENTAL FLOSS
K771400
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
PROPHY PASTE
K771401 · EJR
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
EASE (MODIFICATION TO)
K771403 · EJJ
L.D. Caulk Co.
Dental · 24d
Cleared Aug 22, 1977
MULTI-CAVITY EQUILIBRIUM CELL
K771434
Techhnilab Instruments, Inc.
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CPK TEST
K771441 · CGS
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III UREA NITROGEN TEST
K771442 · CDN
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
MULTISTAT III CREATININE TEST
K771443 · CGX
Instrumentation Laboratory CO
Chemistry · 21d
Cleared Aug 22, 1977
FLUID HANDLING DEVICE W/INPUT TUBING
K771453 · FPA
Imed Corp.
General Hospital · 19d