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
164329–164352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1981
EXECUTIVE COLLAR
K811298 · IQK
Orthomedics
Physical Medicine · 16d
Cleared May 27, 1981
TUBMATE
K811301 · ILS
American Stair-Glide Corp.
Physical Medicine · 16d
Cleared May 27, 1981
LIQUID CHROMATOGRAPHY COLUMNS
K811304 · DPM
Supelco, Inc.
Toxicology · 16d
Cleared May 27, 1981
COAT-A-COUNT T4 RIA KIT
K811315 · CDX
Diagnostic Products Corp.
Chemistry · 16d
Cleared May 21, 1981
FLUID WARMER
K803249 · LGZ
Datachem, Inc.
General Hospital · 149d
Cleared May 21, 1981
ROLL-A-SET
K810918 · FRG
Principle Business Ent.
General Hospital · 45d
Cleared May 21, 1981
MALE LUER LOCK PLUGS
K810921 · FPA
Procedure Products, Inc.
General Hospital · 45d
Cleared May 21, 1981
SYSTEM 400
K810973 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 41d
Cleared May 21, 1981
PREFILLED PULSATOR SYRINGE
K810995 · FMF
Concord Laboratories, Inc.
General Hospital · 38d
Cleared May 21, 1981
BETA I & BETA II
K811082 · IZL
Porta Ray, Inc.
Radiology · 30d
Cleared May 21, 1981
SUR-FIT DISPOSABLE FANGE CAP
K811163 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 23d
Cleared May 21, 1981
FOCUS STERILE SYRINGES
K811167 · FMF
Stanford Laboratories
General Hospital · 23d
Cleared May 21, 1981
MARZ-175
K811199 · CBT
Emde Corp.
Anesthesiology · 21d
Cleared May 21, 1981
EFTEKHAR ACETABULAR STANDOFF
K811201
Zimmer, Inc.
Orthopedic · 20d
Cleared May 21, 1981
SAF SINGLE-USE AEROSOL FILTER
K811203 · GCY
Sorensen Research
General & Plastic Surgery · 20d
Cleared May 21, 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · DTR
Shiley, Inc.
Cardiovascular · 20d
Cleared May 21, 1981
MOLDED POLYSULFONE TRIAL PROSTHESIS
K811205 · HWT
Shannon Group
Orthopedic · 20d
Cleared May 21, 1981
SELF HEATING DISPOSABLE HEAT PAD
K811206 · IMD
Ensar Corp.
Physical Medicine · 20d
Cleared May 21, 1981
MODEL 1100 SPHYGMOMANOMETER
K811208 · DSK
Y
Cardiovascular · 20d
Cleared May 21, 1981
DIGOXIN (RIA) KIT
K811212 · DNL
Immuno Assay Corp.
Toxicology · 17d
Cleared May 21, 1981
ASSURE NATURAL FIT TAMPON
K811214 · HIL
Personal Products Co.
Obstetrics & Gynecology · 17d
Cleared May 21, 1981
KOVA STRIP 6
K811219 · JIR
Icl Scientific
Microbiology · 17d
Cleared May 21, 1981
INORGANIC PHOSPHORUS REAGENTS
K811222 · CED
Connecticut Diagnostics, Ltd.
Chemistry · 17d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223 · KOA
Biomet, Inc.
Gastroenterology & Urology · 17d