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
164641–164664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1981
ORTHOSIS BANDAGES
K810877 · ITG
Ortho-Cast, Inc.
Physical Medicine · 17d
Cleared Apr 17, 1981
ELECTRO-SUCTION UNIT
K810892 · KDQ
Jedmed Instrument Co.
General Hospital · 15d
Cleared Apr 17, 1981
VENTI-GARD JR.
K810896 · KGX
Con Med Equipment, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 1981
MICRO CAUTERY
K810909 · HAM
Key Medical, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 1981
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · DWE
Medrad, Inc.
Cardiovascular · 11d
Cleared Apr 17, 1981
CHORIO-SHURE
K810936 · JHI
Nuclear Medical Laboratories, Inc.
Chemistry · 10d
Cleared Apr 17, 1981
AMES TDA TOBRAMYCIN TEST
K810941 · LCR
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
AMES TDA GENTAMICIN TEST
K810942 · LCQ
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
AMES TDA THEOPHYLLINE TEST
K810943 · LER
Miles Laboratories, Inc.
Toxicology · 10d
Cleared Apr 17, 1981
RADIOIMMUNOASSAY THYROID STIM. HORM. KIT
K810948 · JLW
Endocrine-Metabolic Center
Chemistry · 10d
Cleared Apr 17, 1981
CORNING VITAMIN B12 FOLATE DEFIC. CONTR.
K810952 · JJY
Corning Medical & Scientific
Chemistry · 10d
Cleared Apr 17, 1981
MARCOVE HUMERAL ROD
K810956 · HSB
Hexcel Medical
Orthopedic · 10d
Cleared Apr 17, 1981
MARCOVE INTRAMEDULLARY ROD
K810957 · HSB
Hexcel Medical
Orthopedic · 10d
Cleared Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · JIS
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
K810964 · JIX
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Apr 17, 1981
DATA-ZYME TRIGLYCERIDE
K810965 · CDT
Data Medical Associates, Inc.
Chemistry · 9d
Cleared Apr 16, 1981
PACE AID
K811028
Cardiac Resucitator Corp.
Cardiovascular
Cleared Apr 15, 1981
UTENSIL & PROCEDURE TRAYS
K810242 · FRL
American Hospital Supply Corp.
General Hospital · 77d
Cleared Apr 14, 1981
VAP 2001
K801181
Blendette Intl. , Ltd.
General Hospital · 333d
Cleared Apr 14, 1981
THROMBOPLASTIN
K810350 · GJS
Pacific Hemostasis
Immunology · 63d
Cleared Apr 14, 1981
SR-IVOSEAL
K810523 · ELW
J. Aderer, Inc.
Dental · 47d
Cleared Apr 14, 1981
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE
K810603 · DXY
Telectronics, Inc.
Cardiovascular · 39d
Cleared Apr 14, 1981
ELECTRODE/PACER SYSTEM ANALYZER PMA 400
K810604 · DTC
Telectronics, Inc.
Cardiovascular · 39d
Cleared Apr 14, 1981
SR-IVOSEAL(SOFT RELINING)
K810656
J. Aderer, Inc.
Dental · 47d