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
138529–138552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1987
INTERNATIONAL MODEL XM BEHIND-THE-EAR
K873800 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 32d
Cleared Oct 20, 1987
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
K873814 · DHB
Incstar Corp.
Immunology · 29d
Cleared Oct 20, 1987
ALBUMIN IN SERUM
K873862 · DCF
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
HAPTOGLOBIN
K873866 · DAD
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · LKL
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
REUSEABLE BREATHING TUBES
K873927 · BZO
Dryden Corp.
Anesthesiology · 25d
Cleared Oct 20, 1987
CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS
K873943 · CAZ
Arrow Intl., Inc.
Anesthesiology · 22d
Cleared Oct 20, 1987
RORERTAZZI NASOPHARYNGEAL AIRWAY
K873949 · BTQ
Penn Medical Devices, Inc.
Anesthesiology · 22d
Cleared Oct 20, 1987
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 20d
Cleared Oct 20, 1987
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054 · GGK
Fisher Scientific Co., LLC
Hematology · 15d
Cleared Oct 20, 1987
PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE
K874075 · GXY
Weaver & Co.
Neurology · 14d
Cleared Oct 19, 1987
URIC ACID PAP
K873363 · KNK
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Oct 19, 1987
VEHICLE, MOTORIZED (3-WHEELED ELECTRIC CART)
K873609 · INI
American Dynatec Corp.
Physical Medicine · 41d
Cleared Oct 19, 1987
GEMSTAR II SYSTEM
K873617 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 41d
Cleared Oct 19, 1987
CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
K873749 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 34d
Cleared Oct 19, 1987
COHERENT XA-30 CO2 SURGICAL LASER
K873963 · GEX
Coherent Medical Group
General & Plastic Surgery · 20d
Cleared Oct 16, 1987
NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR)
K872871 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 87d
Cleared Oct 16, 1987
EDI 320
K873599 · KQX
Cybex
Neurology · 42d
Cleared Oct 16, 1987
MAMMOGRAPHIC KVP METER MODEL 232
K873836 · IZH
Radiation Measurements, Inc.
Radiology · 25d
Cleared Oct 15, 1987
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · KPE
Churchill Corp.
General Hospital · 258d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426 · GQO
Armkel, LLC
Microbiology · 189d
Cleared Oct 15, 1987
VACU-AIDE
K872094 · JCX
The Devilbiss Co.
General & Plastic Surgery · 136d
Cleared Oct 15, 1987
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
K872247 · LSR
Whittaker Bioproducts, Inc.
Microbiology · 126d
Cleared Oct 15, 1987
CHURCHILL-CATH
K872585 · FOZ
Churchill Corp.
General Hospital · 106d