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
173593–173616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1977
GUTTA GUN
K771406 · EIC
Aus-Tex Dental Mfg. & Design
Dental · 28d
Cleared Aug 26, 1977
CANNULA CLAMP
K771419 · FKC
Quinton, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 26, 1977
TUBE OCCLUDING FORCEPS
K771424 · KOC
Quinton, Inc.
Gastroenterology & Urology · 25d
Cleared Aug 26, 1977
INFUSION ACCELERATOR
K771458 · KZD
Terumo America, Inc.
General Hospital · 22d
Cleared Aug 26, 1977
AERO PULSE ALTERNATING PRES. PUMP
K771463 · FNM
Medline Industries, Inc.
General Hospital · 22d
Cleared Aug 26, 1977
STETHOSCOPE
K771504 · DQD
Swartz Medical Equipment
Cardiovascular · 21d
Cleared Aug 26, 1977
STETHOSCOPE
K771505 · DQD
Swartz Medical Equipment
Cardiovascular · 21d
Cleared Aug 26, 1977
STETHOSCOPE
K771506 · DQD
Swartz Medical Equipment
Cardiovascular · 21d
Cleared Aug 26, 1977
SPECIALIST ARM & LEG PROTECTOR
K771519 · FMP
Johnson & Johnson Professionals, Inc.
General Hospital · 18d
Cleared Aug 26, 1977
SPIROMETEO & LUNG EXERCISER, 4601
K771532 · BWF
Boehringer Laboratories
Anesthesiology · 16d
Cleared Aug 26, 1977
BIOTRON 18
K771534 · QJQ
Biotronics Corp.
Neurology · 16d
Cleared Aug 26, 1977
CLINICAL EMG MODEL 133
K771577 · HCC
Calnor of EL Paseo, Inc.
Neurology · 8d
Cleared Aug 26, 1977
STETHOSCOPE, NURSESCOPE TYPE
K771581 · DQD
Swartz Medical Equipment
Cardiovascular · 8d
Cleared Aug 26, 1977
WILL-CERAM W-3
K771596 · EJS
Williams Gold Refining Co., Inc.
Dental · 7d
Cleared Aug 26, 1977
PATELLA PROSTHESIS/TRAIL COMPONENT
K771598 · JWH
Depuy, Inc.
Orthopedic · 7d
Cleared Aug 25, 1977
HEMOX-ANALYZER
K771253 · CHL
3M Company
Chemistry · 45d
Cleared Aug 25, 1977
CEBTRIA DIGOXIN RIA
K771255 · DON
Union Carbide Corp.
Toxicology · 44d
Cleared Aug 25, 1977
125 I ALDOSTERONE RIA KIT
K771526 · CJM
Diagnostic Products Corp.
Toxicology · 17d
Cleared Aug 25, 1977
TEMP. CROWN ACRYLIC RESIN
K771530 · EBG
J. Palmero Sales Co., Inc.
Dental · 17d
Cleared Aug 25, 1977
DIGOXIN RIA KIT
K771533 · DNJ
G.D. Searle and Co.
Toxicology · 15d
Cleared Aug 25, 1977
FETAL MONITORING SYSTEM
K771541 · HGM
Air-Shields, Inc.
Obstetrics & Gynecology · 14d
Cleared Aug 25, 1977
VERSATOME
K771549 · IZF
Kermath Mfg. Corp.
Radiology · 13d
Cleared Aug 25, 1977
SPIRAL SCALP ELECTRODE, 14499A
K771553 · HGP
Hewlett-Packard Co.
Obstetrics & Gynecology · 13d
Cleared Aug 25, 1977
HEMA-TEK II SLIDE STAINER
K771559 · KPA
Miles Laboratories, Inc.
Hematology · 10d