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
154153–154176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1984
MONITOR 5590- ANALYZER 5595EC
K840565 · CCL
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 54d
Cleared Apr 02, 1984
AMIKACIN REAGENT TEST KIT
K840647 · LDN
Beckman Instruments, Inc.
Immunology · 47d
Cleared Apr 02, 1984
PULMONARY FUNCTION SYS-3000
K840711 · BZC
Med-Science Electronics, Inc.
Anesthesiology · 45d
Cleared Apr 02, 1984
BIOSPAL 3000S
K840811 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 2400S
K840812 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 1200S
K840813 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Apr 02, 1984
HOSPAL MODEL H1210
K840814 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Apr 02, 1984
MEDICAL LASER ENDOCOAGULATOR 5K
K840854 · HQF
Hgm, Inc.
Ophthalmic · 38d
Cleared Apr 01, 1984
MEDI-TRACE QUIKSET DX DIAG. ELECT-
K834445 · DRX
Graphic Controls Corp.
Cardiovascular · 107d
Cleared Apr 01, 1984
IMMPULSE TBC ASSAY REAGENTS
K840853 · KHQ
Paragon Diagnostics, Inc.
Chemistry · 37d
Cleared Mar 30, 1984
INTRAVENOUS NEEDLE
K832904 · FMI
Yolan R. Guttman
General Hospital · 214d
Cleared Mar 30, 1984
BSD-200
K833158 · FLL
Bsd Medical Corp.
General Hospital · 196d
Cleared Mar 30, 1984
HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST
K833304 · DZM
Smith & Nephew, Mpl Division
Dental · 189d
Cleared Mar 30, 1984
PRE-LOADED C-R TUBES FOR SYRINGE
K833725 · EBF
Centrix, Inc.
Dental · 158d
Cleared Mar 30, 1984
CANAL HEARING AID
K833773 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 155d
Cleared Mar 30, 1984
VASCULAR ACCESS CATH. REPAIR KIT
K833915 · LJS
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 137d
Cleared Mar 30, 1984
WESCOR 5500 VAPOR PRESSURE OSMOMETER
K834214 · JJM
Wescor, Inc.
Chemistry · 116d
Cleared Mar 30, 1984
NIGHT TRAINER
K834311 · KPN
Maddak, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 30, 1984
KEATES IRRIGATION/ASPIRATION/VITREOUS
K834437 · HQE
Frigitronics of Connecticut, Inc.
Ophthalmic · 102d
Cleared Mar 30, 1984
POCKETIP 4414
K834545 · EFS
Vipont Laboratories, Inc.
Dental · 94d
Cleared Mar 30, 1984
MENSTRUAL PADS
K834564 · HHL
Probel-U.S., Inc.
Obstetrics & Gynecology · 93d
Cleared Mar 30, 1984
VENTILATORY FREQUENCY MONITOR
K834569 · BZO
Cryo Corp.
Anesthesiology · 92d
Cleared Mar 30, 1984
CHEMODENT CERAMIC METAL
K840014 · EJS
Chemodent Metal Co.
Dental · 86d
Cleared Mar 30, 1984
COLTENE BRILLIANT LUX
K840084 · EBF
Bauer, Cheng & Associates, Inc.
Dental · 80d