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
161569–161592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1982
MARK 500 ULTRASOUOND SYSTEM
K820364 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 45d
Cleared Mar 26, 1982
MARK 100 & 300 ULTRASOUND SYSTEM
K820365 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 45d
Cleared Mar 26, 1982
JLS GROUP INFANT MONITOR
K820374 · BZQ
Jls Group, Inc.
Anesthesiology · 45d
Cleared Mar 26, 1982
AVES WRIGHT STAIN
K820437 · IAF
Helena Laboratories
Pathology · 37d
Cleared Mar 26, 1982
THROMBOSCREEN
K820450 · GIT
Pacific Hemostasis
Hematology · 36d
Cleared Mar 26, 1982
INTRODUCER FOR ENDOTRACHEAL TUBE
K820451 · BWB
Imed Corp.
Anesthesiology · 36d
Cleared Mar 26, 1982
ACCU-RYNGE INSULIN PUMP #SP-250
K820482 · FRN
Delta Medical Industries
General Hospital · 32d
Cleared Mar 26, 1982
SODIUM PYRUVATE (100MM)
K820495 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
MEM NON-ESSENTIAL AMINO ACIDS (100X)
K820508 · KIT
Dutchland Laboratories, Inc.
Chemistry · 31d
Cleared Mar 26, 1982
7CM BERMAN AIRWAY
K820512 · CAE
Vital Signs, Inc.
Anesthesiology · 29d
Cleared Mar 26, 1982
PFLEX TM
K820528 · BWF
Health Scan, Inc.
Anesthesiology · 25d
Cleared Mar 26, 1982
WET PACK LINE OF PRODUCTS
K820587 · KMJ
Abco Dealers, Inc.
General Hospital · 22d
Cleared Mar 26, 1982
ORTHOPEDIC SOFT GOODS
K820590 · ILI
Abco Dealers, Inc.
Physical Medicine · 22d
Cleared Mar 26, 1982
CYANMETHEMOGLOBIN TEST
K820596 · KHG
Boehringer Mannheim Corp.
Hematology · 22d
Cleared Mar 26, 1982
158 BLOOD GAS ANALYZER
K820597 · CHL
Corning Medical & Scientific
Chemistry · 22d
Cleared Mar 26, 1982
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
K820616 · CIB
E. R. Squibb & Sons, Inc.
Toxicology · 18d
Cleared Mar 26, 1982
TRICHROME STAIN
K820634 · HYC
Volu Sol Medical Industries
Pathology · 18d
Cleared Mar 26, 1982
STORZ #6500 POWER EXAMINATION CHAIR
K820636 · GBB
Storz Instrument Co.
General & Plastic Surgery · 18d
Cleared Mar 26, 1982
HOO2D SEAT-INFANT
K820640 · BYL
Dhd Medical Products Div. Diemolding...
Anesthesiology · 18d
Cleared Mar 26, 1982
BALLARD MEDICAL PRODUCTS ELECTRO-SURG
K820713 · GEI
Ballard Medical Products
General & Plastic Surgery · 11d
Cleared Mar 25, 1982
HYPODERMIC & SUTURE NEEDLES
K813256 · FMI
Needle Industries(Usa), Inc.
General Hospital · 126d
Cleared Mar 25, 1982
SALICYLATES
K813431 · DKJ
Bio-Analytics Laboratories, Inc.
Toxicology · 107d
Cleared Mar 25, 1982
AUTO SECTOR MCU
K813596 · IYO
Technicare Corp.
Radiology · 87d
Cleared Mar 25, 1982
CONTINUOUS BLOOD PROCESSOR CBP-6000 &
K820243 · KDI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 55d