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
141601–141624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · DXK
Advanced Technology Laboratories, Inc.
Cardiovascular · 66d
Cleared Feb 02, 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · LJP
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 66d
Cleared Feb 02, 1987
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · DDC
Miles Laboratories, Inc.
Immunology · 41d
Cleared Feb 02, 1987
REVISED T-SCAN SYSTEM
K870032 · EFH
Sentek, Inc.
Dental · 28d
Cleared Jan 30, 1987
HPD HUMIDIFYING CHAMBER
K864173 · BTT
Hpd Medical, Inc.
Anesthesiology · 98d
Cleared Jan 30, 1987
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K864225 · FAD
Angiomed U.S., Inc.
Gastroenterology & Urology · 94d
Cleared Jan 30, 1987
EMG-1, MOTOR NERVE MONITOR
K864408 · IKN
Algotek, Inc.
Neurology · 81d
Cleared Jan 30, 1987
MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM
K864837 · JAA
Oec-Diasonics, Inc.
Radiology · 52d
Cleared Jan 30, 1987
MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA
K864903 · CCK
Salter Labs
Anesthesiology · 46d
Cleared Jan 30, 1987
ALPHA II DIAGNOSTIC X-RAY
K864958 · IZH
Ausonics Pty , Ltd.
Radiology · 43d
Cleared Jan 29, 1987
BLOOD LANCET
K850100 · FMK
Gainor Medical
General & Plastic Surgery · 748d
Cleared Jan 29, 1987
EVOPORT 100
K863985 · GWJ
Jedmed Instrument Co.
Neurology · 107d
Cleared Jan 29, 1987
NTE-2 THERMAL SENSITIVITY TESTER
K864345 · LQW
Sensortek, Inc.
Neurology · 86d
Cleared Jan 29, 1987
COLTENE RAPID
K870047 · ELW
Coltene, Inc.
Dental · 23d
Cleared Jan 28, 1987
RESPIRADYNE II(TM)
K863866 · BZK
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 117d
Cleared Jan 28, 1987
ALPINE
K864005 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 105d
Cleared Jan 28, 1987
BROOKER BIO-GROOVE FEMORAL COMPONENT
K864085 · KWL
Biomet, Inc.
Orthopedic · 100d
Cleared Jan 28, 1987
CURITY ANESTHESIA FILTER
K864103 · CAH
The Kendal Co.
General Hospital · 99d
Cleared Jan 28, 1987
ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT
K864280 · BYJ
Smith-Taylor Mfg. Co., Div. Allied...
Anesthesiology · 90d
Cleared Jan 28, 1987
LIFEWATCH SENSOR BELT
K864487 · BZQ
Lifewatch Systems, Inc.
Anesthesiology · 76d
Cleared Jan 28, 1987
VENTEX-IA
K864641 · IKN
Ventech Corp.
Neurology · 63d
Cleared Jan 28, 1987
KOTEX SECURITY TAMPONS, REGULAR AND SUPER
K864750 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 54d
Cleared Jan 28, 1987
NEONATAL CANNULA CAP
K864883 · BZD
Behan & Taylor Ent.
Anesthesiology · 47d
Cleared Jan 28, 1987
MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.
K864902 · CCK
Salter Labs
Anesthesiology · 44d