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
145009–145032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1986
ASSERACHROM VWF KIT
K860371 · GGP
American Bioproducts Co.
Hematology · 60d
Cleared Apr 04, 1986
CLAMP-N-CUT
K860445 · HFW
Mmi, Inc.
Obstetrics & Gynecology · 59d
Cleared Apr 04, 1986
FILTRA-CHECK-UTI
K860483 · JXA
Applied Polytechnology, Inc.
Microbiology · 53d
Cleared Apr 04, 1986
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM
K860504 · ITY
Victoreen, Inc.
Radiology · 52d
Cleared Apr 04, 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · KYG
Staar Surgical Co.
Ophthalmic · 50d
Cleared Apr 04, 1986
MUREX SUDS GROUP A STREP
K860576 · GTZ
Murex Corp.
Microbiology · 45d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · GTZ
Hybritech, Inc.
Microbiology · 32d
Cleared Apr 04, 1986
URICHECK
K860905 · JXA
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Apr 04, 1986
EYEMETER
K860928
Indivisual Corporation, Inc.
Ophthalmic · 24d
Cleared Apr 04, 1986
ABSORBENT, FIBER, OPERATING ROOM TOWELS
K860936 · KKX
Ulti-Med Intl., Inc.
General Hospital · 23d
Cleared Apr 04, 1986
VIRTRAN VIRAL TRANSPORTER (MODIFIED)
K860967 · JSN
Diagnon Corp.
Microbiology · 25d
Cleared Apr 04, 1986
DONALDSON NATURAL EYEPATCH
K860979 · HMP
Keeler Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-2001
K861011 · CAW
Medical Devices, Inc.
Anesthesiology · 17d
Cleared Apr 04, 1986
SILENT PARTNER MODEL 10-1001
K861012 · CAW
Medical Devices, Inc.
Anesthesiology · 17d
Cleared Apr 04, 1986
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS
K861022 · JTR
Micro-Bio-Logics
Microbiology · 17d
Cleared Apr 04, 1986
SUPERLITE PENLIGHT
K861028
Keta Corp.
Ophthalmic · 17d
Cleared Apr 04, 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
NIDEK KM-800 AUTO KERATOMETER
K861063 · HLQ
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · HKO
Nidek, Inc.
Ophthalmic · 15d
Cleared Apr 04, 1986
PB 254 IR - SPECTROMETER
K861213 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 4d
Cleared Apr 03, 1986
PSP C & B TEMP
K853092 · EBG
Psp Dental Co., Ltd.
Dental · 254d
Cleared Apr 03, 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
K855059 · LXB
Xomed, Inc.
Ear, Nose, Throat · 106d
Cleared Apr 03, 1986
SGOT (AST) REAGENT SET
K860216 · CIQ
Sterling Diagnostics, Inc.
Chemistry · 71d
Cleared Apr 03, 1986
MARDIS DANGLER URETERAL STENT SET
K860267 · FAD
Van-Tec, Inc.
Gastroenterology & Urology · 66d