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
144577–144600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · JWY
Gibco Laboratories Life Technologies,...
Microbiology · 68d
Cleared May 06, 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · FMI
Icu Medical, Inc.
General Hospital · 64d
Cleared May 06, 1986
DUAL-AID
K860949 · CAE
Vitalograph , Ltd.
Anesthesiology · 55d
Cleared May 06, 1986
FLUID MANAGEMENT SYSTEM (MODIFIED)
K860969 · FRN
Haemonetics Corp.
General Hospital · 56d
Cleared May 06, 1986
SITE DISPOSABLE CASSETTE
K860989 · HQC
Microsurgical Systems, Inc.
Ophthalmic · 50d
Cleared May 06, 1986
KETA HAND-HELD TONOMETER
K861027 · HKS
Keta Corp.
Ophthalmic · 49d
Cleared May 06, 1986
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · GEI
Valleylab, Inc.
General & Plastic Surgery · 49d
Cleared May 06, 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 47d
Cleared May 06, 1986
THE NEW FLEXIBLE COLLAPSIBLE CHAMBER
K861101 · KPJ
Stephenson Industries, Inc.
General & Plastic Surgery · 43d
Cleared May 06, 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · FMI
Exel Intl.
General Hospital · 41d
Cleared May 06, 1986
XTAL X-800 SHADOWGRAPH
K861163
Xtal Corp.
Ophthalmic · 39d
Cleared May 06, 1986
NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES
K861288 · KKX
Procedure Pak, Inc.
General Hospital · 29d
Cleared May 06, 1986
FASICULATED NAIL
K861365 · HSB
Lake Region Mfg., Inc.
Orthopedic · 25d
Cleared May 06, 1986
PRE-CHECK C02 DETECTOR
K861398 · CCK
Alleghany Intl. Medical Technology
Anesthesiology · 21d
Cleared May 06, 1986
NON-KOR WINGED INFUSION SETS
K861406 · FMI
Creative Care Systems, Inc.
General Hospital · 21d
Cleared May 06, 1986
VEOLAR VENTILATOR
K861432 · CBK
Hamilton Medical, Inc.
Anesthesiology · 20d
Cleared May 06, 1986
CHURCHILL FEMALE LUER LOCK CAP
K861439 · FPA
Churchill Corp.
General Hospital · 19d
Cleared May 06, 1986
S1 VAGINAL PACKING
K861443 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 NASAL PACKING
K861444 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 CAVITY PACKING
K861445 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
S1 ORAL PACKING
K861446 · EFQ
Surgical Specialties, Inc.
General & Plastic Surgery · 19d
Cleared May 06, 1986
STAGNONE SWIVEL-JOINT NEEDLE
K861453
Radtech, Inc.
General & Plastic Surgery · 18d
Cleared May 06, 1986
END TIDAL CO2 TUBE
K861454 · BTR
Sheridan Catheter Corp.
Anesthesiology · 18d
Cleared May 06, 1986
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · BTR
Shiley, Inc.
Anesthesiology · 15d