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
147769–147792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1985
MALIS BIPOLAR PEN
K853168 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 13d
Cleared Aug 12, 1985
ULTRACLONE ECL-01-2200 CELL LINE
K853203 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 13d
Cleared Aug 12, 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K853244 · CEK
Simmler, Inc.
Chemistry · 11d
Cleared Aug 09, 1985
RADI-BIOPSY DEVICE
K850605 · KNW
Radiplast AB
Gastroenterology & Urology · 175d
Cleared Aug 09, 1985
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
K851897 · DTD
Cardiac Control Systems, Inc.
Cardiovascular · 101d
Cleared Aug 09, 1985
MECTA ECT DEVICE MODELS SR & JR
K852069 · QGH
Mecta Corp.
Neurology · 91d
Cleared Aug 09, 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · DTL
Terumo Medical Corp.
Cardiovascular · 88d
Cleared Aug 09, 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 86d
Cleared Aug 09, 1985
FOAM ECG ELECTRODES
K852177 · DRX
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Aug 09, 1985
BELIEVE LABIAL PADS
K852226 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 79d
Cleared Aug 09, 1985
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · DXS
Dlp, Inc.
Cardiovascular · 79d
Cleared Aug 09, 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · HQE
CooperVision, Inc.
Ophthalmic · 73d
Cleared Aug 09, 1985
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351 · KWA
Kirschner Medical Corp.
Orthopedic · 70d
Cleared Aug 09, 1985
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
K852363 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 66d
Cleared Aug 09, 1985
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129)
K852397 · JEC
Howmedica Corp.
Orthopedic · 64d
Cleared Aug 09, 1985
TOTAL CPM
K852399 · BXB
Invacare Corp.
Physical Medicine · 64d
Cleared Aug 09, 1985
PULMONARY VEIN CLAMP
K852479 · DXC
None
Cardiovascular · 59d
Cleared Aug 09, 1985
CO2 FOR ARTHROSCOPY
K852592 · HRX
The Anspach Effort, Inc.
Orthopedic · 51d
Cleared Aug 09, 1985
MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE
K852679 · LKX
J. & Jp., Inc.
Gastroenterology & Urology · 45d
Cleared Aug 09, 1985
URETERAL DILATOR/SHEATH SET
K852793 · EZN
American Edwards Laboratories
Gastroenterology & Urology · 39d
Cleared Aug 09, 1985
CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION
K852956 · GYB
Parker Laboratories, Inc.
Neurology · 29d
Cleared Aug 09, 1985
PROTECTIVE PAD FOR INCONTINENCE
K853079 · EYQ
I.C.D. Industries, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 09, 1985
SPECTACLE PRESCRIPTION LENSES
K853110 · HQG
Ancie Laboratories
Ophthalmic · 16d
Cleared Aug 09, 1985
VISITEC 2 MICRON FLUID FILTER
K853135 · HQE
Visitec Co.
Ophthalmic · 14d