FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150265–150288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1984
SPECTABLE FRAME MAGNIFYING BRILLETTE
K844657 · HOJ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 11, 1984
SPECTABLE FRAME - PRODESIGN SUN CLUB
K844658 · HQZ
Pro Design Intl. AS
Ophthalmic · 12d
Cleared Dec 10, 1984
MECHANICAL SECTOR PROBE 4 MHZ DFM
K842880 · IYO
General Electric Co.
Radiology · 140d
Cleared Dec 10, 1984
STERILE WATER
K843796
Paco Pharmaceutical Services, Inc.
Cardiovascular · 74d
Cleared Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
K844021 · CGZ
Advanced Biomedical Methods, Inc.
Chemistry · 56d
Cleared Dec 10, 1984
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A
K844164 · DII
Lkb Instruments, Inc.
Chemistry · 46d
Cleared Dec 10, 1984
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
K844171 · LGR
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281 · LCX
Healthcheck Corp.
Chemistry · 35d
Cleared Dec 10, 1984
ABL300 ACID BASE LABORATORY
K844295 · CHL
Radiometer America, Inc.
Hematology · 34d
Cleared Dec 10, 1984
COAT-A-COUNT ANDROSTENEDIONE RIA KIT
K844398 · CIZ
Diagnostic Products Corp.
Chemistry · 27d
Cleared Dec 10, 1984
SANDARE ALKALINE PHOSPHATASE PROCEDURE
K844498 · CIO
Sandare Chemical Co., Inc.
Chemistry · 20d
Cleared Dec 07, 1984
REPLACE-A-TIP ADJUST. LOW TEMP.-
K841459 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 242d
Cleared Dec 07, 1984
REPLACE-A-TIP ADJUSTABLE HIGH TEMP.
K841509 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 240d
Cleared Dec 07, 1984
ADJUST-A-TEMP MICRO
K841603 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 232d
Cleared Dec 07, 1984
ADJUST-A-TEMP HIGH TEMPERATURE
K841604 · GEI
Suncoast Medical Manufacturers, Inc.
General & Plastic Surgery · 232d
Cleared Dec 07, 1984
PERCUTANEOUS GASTROSTOMY TUBE
K842174 · KNT
Mount Carmel Mercy Hospital
Gastroenterology & Urology · 184d
Cleared Dec 07, 1984
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370 · DXH
Hewlett-Packard Co.
Cardiovascular · 175d
Cleared Dec 07, 1984
ACU-PATCH
K842946 · KGX
Acutek
General & Plastic Surgery · 134d
Cleared Dec 07, 1984
MC-4000 CONSOLE & PROBES
K842959 · GEH
Cryomedics, Inc.
General & Plastic Surgery · 133d
Cleared Dec 07, 1984
TOP HYPODERMIC SYRINGE LUER LOCK
K843415 · FMF
Top Surgical Manufacturers Co.
General Hospital · 98d
Cleared Dec 07, 1984
MINUTEMAN CO2 MICROSURG LASER DERMATOL-
K843517 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
MINUTEMAN C02 MICROSURG LASER PODIATRY
K843518 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
MINUTEMAN CO2 MICROSURG LASER GEN SURG
K843519 · GEY
American Surgical Laser, Inc.
General & Plastic Surgery · 93d
Cleared Dec 07, 1984
IV JET
K843887 · FMF
Nuclear Concepts, Inc.
General Hospital · 66d