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
159145–159168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1982
PRISMA-C-REACTIVE PROTEIN CALIBRATORS
K823417 · DCK
Syva Co.
Chemistry · 24d
Cleared Dec 09, 1982
MICROSURGICAL GAUGE
K823436 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 09, 1982
MCGEE 26GA. SUCTION TUBE
K823437 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Dec 09, 1982
STAINLESS STEEL PISTONS
K823483 · ETB
Humboldt Products
Ear, Nose, Throat · 16d
Cleared Dec 09, 1982
BIRT-A-PAD #730
K823492
Birtcher Corp.
General & Plastic Surgery · 16d
Cleared Dec 09, 1982
NASAL CANNULA
K823506 · CAT
Seven Harvest Intl. Import & Export
Anesthesiology · 15d
Cleared Dec 07, 1982
DERM-A-TEC SKIN BARRIER FILM
K822713
Professional Medical Products, Inc.
General & Plastic Surgery · 91d
Cleared Dec 07, 1982
ELECTROSURGICAL UNIT
K823083 · GEI
Kelleher Corp.
General & Plastic Surgery · 49d
Cleared Dec 07, 1982
NEUROTRAC
K823116 · GWQ
Interspec, Inc.
Neurology · 47d
Cleared Dec 07, 1982
ELECTROENCEPHALOGRAPH
K823140 · GWQ
Nihon Kohden America, Inc.
Neurology · 36d
Cleared Dec 07, 1982
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY
K823231 · CCL
Yellow Springs Instrument Co., Inc.
Anesthesiology · 39d
Cleared Dec 07, 1982
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
K823232 · CCL
Yellow Springs Instrument Co., Inc.
Anesthesiology · 39d
Cleared Dec 07, 1982
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · EXD
Howmedica Corp.
Gastroenterology & Urology · 34d
Cleared Dec 07, 1982
PORTABLE SHOWER BATH
K823327 · ILM
Wall Manufacturer, Inc.
Physical Medicine · 29d
Cleared Dec 07, 1982
NEPHROSS, ANDANTE H.F.
K823375 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 25d
Cleared Dec 07, 1982
BE#1000-INSTANT ON/OFF O2 VALVE
K823408 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 22d
Cleared Dec 03, 1982
IRRIGATION SET
K822560 · NBH
Utah Medical Products, Inc.
Orthopedic · 101d
Cleared Dec 03, 1982
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682 · DHN
Amico Lab, Inc.
Microbiology · 91d
Cleared Dec 03, 1982
SIGMA REAGENT SYSTEM NO. 885
K822733 · JBE
Sigma Chemical Co.
Hematology · 86d
Cleared Dec 03, 1982
MYCOTRIUM-GU
K822736 · JSI
Hana Biologics, Inc.
Microbiology · 85d
Cleared Dec 03, 1982
MYCOTRIUM-RS
K822737 · JSI
Hana Biologics, Inc.
Microbiology · 85d
Cleared Dec 03, 1982
BLOOD GAS EXPER. SYSTEM 8700
K822778 · JQP
Exper Corp., Inc.
Chemistry · 80d
Cleared Dec 03, 1982
ANTIBODY TO MUMPS VIRUS IFA TEST
K822826 · GRA
Electro-Nucleonics Laboratories, Inc.
Microbiology · 73d
Cleared Dec 03, 1982
GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
K822867 · LCP
Isolab, Inc.
Chemistry · 67d