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

Filters: Cleared only ×
176,076 results
166681–166704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1980
HOWMEDICA BITE BLOCK
K801911 · EGD
Howmedica Corp.
Dental · 16d
Cleared Aug 27, 1980
BIOMEGA #423-B BLOOD PRESSURE & PULSE CK
K801923 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 15d
Cleared Aug 27, 1980
MARTIN TRACH-SECURE
K801931 · BTO
Acucare Medical, Inc.
Anesthesiology · 15d
Cleared Aug 27, 1980
DRUALIFT 500
K801933 · FNG
Independent Transfer Equipment Co.
General Hospital · 15d
Cleared Aug 27, 1980
PAD, HOSPITAL STRETCHER
K801935 · FPO
Volunteer Blind Industries, Inc.
General Hospital · 15d
Cleared Aug 27, 1980
PAD, EXAMINING TABLE
K801936 · KMN
Volunteer Blind Industries, Inc.
General Hospital · 15d
Cleared Aug 27, 1980
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · FOZ
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Aug 27, 1980
ASNIS GUIDED SCREW SYSTEMS
K801969 · HNC
Howmedica Corp.
Ophthalmic · 8d
Cleared Aug 22, 1980
AMPCO DRESSING CHANGE TRAYS
K801333 · FRG
Associated Medical Products Co.
General Hospital · 80d
Cleared Aug 20, 1980
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
K801331 · FRG
Associated Medical Products Co.
General Hospital · 78d
Cleared Aug 20, 1980
LATEX FOLEY CATHETER (HYDROMER COATED)
K801415 · KOD
G.D. Searle and Co.
Gastroenterology & Urology · 65d
Cleared Aug 20, 1980
ELECTRO-ACUSCOPE-70
K801459 · GZJ
Nebrensky Corp.
Neurology · 57d
Cleared Aug 20, 1980
BMC RIAFLO SYSTEM
K801481 · JJC
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Aug 20, 1980
ULTRAFREE CALCIUM FILTER
K801500 · JRL
Millipore Corp.
Chemistry · 54d
Cleared Aug 20, 1980
ANTIGEN CONTROL CELLS
K801507 · GOL
Ortho Diagnostics, Inc.
Microbiology · 51d
Cleared Aug 20, 1980
DOPPLER ULTRASONIC STETHOSCOPE
K801512 · IYN
Mountain Medical Equipment, Inc.
Radiology · 51d
Cleared Aug 20, 1980
SOLAR PACIFIC UVA SUNLAMP DEVICE
K801520 · LEJ
Solar Pacific
Radiology · 50d
Cleared Aug 20, 1980
CLASSIC TAN TANNING BOOTH
K801521 · LEJ
Classic Tan, Inc.
Radiology · 50d
Cleared Aug 20, 1980
WALL MOUNTED LASER POSITIONING DEVICE
K801541 · IWE
Advantage Medical Systems, Inc.
Radiology · 48d
Cleared Aug 20, 1980
SUNBED/SUNROOF OR SUNCOUCH/SUNSKY
K801542 · LEJ
Sunfit, Inc.
Radiology · 44d
Cleared Aug 20, 1980
PHOTOMETER LP 6
K801562 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 3
K801563 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
PHOTOMETER LP 1
K801564 · JJQ
Dr. Bruno Lange GmbH
Chemistry · 43d
Cleared Aug 20, 1980
L-CATH INTRAVENOUS PLACEMENT UNIT
K801575 · FOZ
Luther Medical Products, Inc.
General Hospital · 43d