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
147601–147624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1985
OMS/GONVERS RETINAL PERFORATOR
K844448 · HNM
Optical Micro Systems, Inc.
Ophthalmic · 278d
Cleared Aug 21, 1985
ORTHOPEDIC CUSTOM SURGICAL KIT
K844595 · LXH
Xanmed Corp.
Orthopedic · 268d
Cleared Aug 21, 1985
BIO-TENS
K844618 · GZJ
Bio-Research Associates, Inc.
Neurology · 267d
Cleared Aug 21, 1985
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · KXK
Syncor Intl. Corp.
Radiology · 198d
Cleared Aug 21, 1985
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815 · KPT
Victoreen, Inc.
Radiology · 174d
Cleared Aug 21, 1985
INFRARAX DEVICE
K850852 · ILY
Medicon, Inc.
Physical Medicine · 173d
Cleared Aug 21, 1985
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA
K851377 · CDD
Diagnon Corp.
Chemistry · 135d
Cleared Aug 21, 1985
VIBRECTOR
K851646 · LIL
Multicept, Aps.
Gastroenterology & Urology · 124d
Cleared Aug 21, 1985
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023 · KXK
Syncor Intl. Corp.
Radiology · 105d
Cleared Aug 21, 1985
VERSA STIM 380, MUSCLE STIMULATOR
K852077 · IPF
Electro-Med Health Industries, Inc.
Physical Medicine · 100d
Cleared Aug 21, 1985
CHLORIDE REAGENT
K852169 · CHJ
Pointe Scientific, Inc.,
Chemistry · 93d
Cleared Aug 21, 1985
URETERAL DILATOR
K852324 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 83d
Cleared Aug 21, 1985
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K852441 · CJE
Clinical Data, Inc.
Chemistry · 72d
Cleared Aug 21, 1985
RIONET HEARING AID HB-34HT
K852451 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 21, 1985
RIONET HEARING AID HB-71P
K852452 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · JJQ
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Aug 21, 1985
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K852546 · JDI
Howmedica Corp.
Orthopedic · 68d
Cleared Aug 21, 1985
GOUDA FRAME FOR STEREOTACTIC NEUROSURGERY
K852662 · HAW
Neurosurgical Devices, Inc.
Neurology · 58d
Cleared Aug 21, 1985
5F ELECTRODE(LITHOTRIPTOR)
K852874 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 44d
Cleared Aug 21, 1985
OLYMPUS RIGID URETERORENOSCOPE
K852888 · FGB
Olympus Corp.
Gastroenterology & Urology · 43d
Cleared Aug 21, 1985
LEE BONE MARROW BIOPSY/ASPIRATION TRAY
K852897 · GAA
Southland Instruments, Inc.
General & Plastic Surgery · 43d
Cleared Aug 21, 1985
ENTERAL FEEDING PUMP
K852965 · FRN
Empire Industries, Inc.
General Hospital · 40d
Cleared Aug 21, 1985
TRANSFER DEVICE
K853188 · LHI
Advance Medical Designs, Inc.
General Hospital · 22d
Cleared Aug 21, 1985
EASYTOP
K853281
Hydro-Med Products, Inc.
General & Plastic Surgery · 16d