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

Filters: Cleared only ×
176,076 results
170425–170448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1979
DRAPES, DISPOSABLE SURGICAL
K782051 · KKX
Marco Mfg.
General Hospital · 103d
Cleared Mar 21, 1979
CREAM, SIGNA
K782055 · GYB
Parker Laboratories, Inc.
Neurology · 100d
Cleared Mar 21, 1979
SPINAL SURGERY INSTRUMENTATION
K782061 · KWQ
Stuart Drug & Surgical Supply, Inc.
Orthopedic · 100d
Cleared Mar 21, 1979
RIA SYSTEM, PARATHYROID HORMONE
K782081 · CEW
Iso-Tex Diagnostics
Chemistry · 98d
Cleared Mar 21, 1979
PHASEAFILL
K782165 · EBF
Phasealloy
Dental · 85d
Cleared Mar 21, 1979
NEEDLE II, BURRON FILTER
K790060 · GAA
National Patent Development Corp.
General & Plastic Surgery · 70d
Cleared Mar 21, 1979
SERUM PAK, HCG CONTROL
K790129 · JJX
Mallinckrodt Critical Care
Chemistry · 57d
Cleared Mar 21, 1979
SUNLAMP
K790167 · FTC
Kneilsly Group Ent.
General & Plastic Surgery · 64d
Cleared Mar 21, 1979
PORTABLE WHEELCHAIR & CARRYING CASE
K790183 · IOR
Fred Sammons, Inc.
Physical Medicine · 54d
Cleared Mar 21, 1979
NTSH AUTOPAK TEST DELIVERY SYSTEM
K790260 · JLW
Micromedic Systems
Toxicology · 43d
Cleared Mar 21, 1979
DATA-TOPE TRI-RAC RADIOASSAY CONTROL
K790264 · JJY
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
SENSI-TEX
K790267 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 43d
Cleared Mar 21, 1979
MAMMOGRAPHY SYSTEM AND CASSETTE
K790273 · IZH
Agfa-Gevaert, Inc.
Radiology · 41d
Cleared Mar 21, 1979
DIAGNOSTIC SET, LIPO-FRAX
K790281 · LBS
Analytical Products, Inc.
Chemistry · 36d
Cleared Mar 21, 1979
BUFFER, CORNING MOPSO
K790294 · JHX
Corning Medical & Scientific
Chemistry · 41d
Cleared Mar 21, 1979
PRESSURE MONITOR, MODEL 212
K790302 · HRW
Zatek
Neurology · 36d
Cleared Mar 21, 1979
HEMOGLOBIN CONTROLS
K790310 · GGM
Electrophoresis Corp.
Hematology · 36d
Cleared Mar 21, 1979
LDH ISOENZYME REAGENT
K790311 · CFE
Electrophoresis Corp.
Hematology · 36d
Cleared Mar 21, 1979
ORTHO-TOLUIDINE REAGENT SET
K790319 · CGE
Fisher Scientific Co., LLC
Toxicology · 34d
Cleared Mar 21, 1979
COAG-A-MATE 2001
K790323 · JPA
General Diagnostics
Hematology · 34d
Cleared Mar 21, 1979
STIMTECH TENS ELECTRODE
K790345 · GXY
Stimulation Technology, Inc.
Neurology · 28d
Cleared Mar 21, 1979
ACTIVATOR
K790346 · JBP
Tri-Med, Inc.
Hematology · 28d
Cleared Mar 21, 1979
FLUID ADMINISTRATION CAT.#14-923
K790358 · GAZ
Norton Performance Plastics Corp.
General Hospital · 36d
Cleared Mar 21, 1979
HALOTHANE VAPORIZER 950, & ENFLURANE 951
K790359 · CAD
Siemens Corp.
Anesthesiology · 27d