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
158065–158088 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1983
DUAL CHANNEL RECORDER #78574A
K830315 · DSF
Hewlett-Packard Co.
Cardiovascular · 59d
Cleared Mar 31, 1983
INFUSION PUMP ACCESS. #60-01-5
K830317 · FRW
Windsor Medical, Inc.
General Hospital · 59d
Cleared Mar 31, 1983
ABG KITS - CMS 4000 SERIES
K830333 · CBT
Currie Medical Specialties, Inc.
Anesthesiology · 58d
Cleared Mar 31, 1983
AMBULATORY BLOOD PRESSURE MONITOR
K830368 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1983
IMS MINIATURE VOLUMETRIC INFUSION PUMP
K830454 · FRN
Ziehm International, Inc.
General Hospital · 44d
Cleared Mar 31, 1983
TOURNIQUET/LATEX TOURNIQUET
K830467 · GAX
Primeline Industries, Inc.
General & Plastic Surgery · 44d
Cleared Mar 31, 1983
OR PREP KIT
K830476 · FRG
Clinipad Corp.
General Hospital · 44d
Cleared Mar 31, 1983
MODEL 50-01-27
K830490 · FRN
Windsor Medical, Inc.
General Hospital · 44d
Cleared Mar 31, 1983
SCOTTS TAP WATER SUBSTITUTE CONCENTRATE
K830515 · KEQ
Surgipath Medical Industries, Inc.
Pathology · 42d
Cleared Mar 31, 1983
STAINLESS STEEL SUTURE 316L
K830522
Sharpoint, Inc.
General & Plastic Surgery · 42d
Cleared Mar 31, 1983
WINDSOR MEDICAL, INC. 50-01-028
K830544 · FRN
Windsor Medical, Inc.
General Hospital · 37d
Cleared Mar 31, 1983
ERG-JET ELECTRODE
K830557 · HLZ
Universo S.A.
Gastroenterology & Urology · 36d
Cleared Mar 31, 1983
RENALIN (TENTATIVE
K830575 · LIF
Renal Systems, Inc.
Hematology · 36d
Cleared Mar 31, 1983
PUMP PALL AMBULATORY INSULIN INFUSION
K830605 · FRN
Biomedical Devices, Inc.
General Hospital · 34d
Cleared Mar 31, 1983
COMBION SKIN TEST
K830688 · LKH
Nicholas H. Maganias
Immunology · 27d
Cleared Mar 31, 1983
PRIME
K830691 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 30d
Cleared Mar 31, 1983
VENES ANTI EMBOLISM STOCKINGS
K830696 · DWL
Futuro Div. Jung Corp.
General Hospital · 24d
Cleared Mar 31, 1983
WINGED CATHETER
K830765 · FOZ
Abbott Laboratories
General Hospital · 21d
Cleared Mar 31, 1983
WILLIAMS AIRWAY INTUBATOR
K830767 · CAE
Williams Airway Intubator
Anesthesiology · 20d
Cleared Mar 31, 1983
ENDO-GUARD
K830781 · FOG
Jayco Pharmaceuticals
Anesthesiology · 20d
Cleared Mar 29, 1983
MOUTH CARE KIT W/TOOTHBRUSH
K823413
Sage Products, Inc.
Dental · 134d
Cleared Mar 29, 1983
MECON I
K823788 · ESD
Mecon Labs
Ear, Nose, Throat · 103d
Cleared Mar 29, 1983
RMC TOTAL KNEE SYSTEM
K823837 · MBV
Richard'S Medical Equip., Inc.
Orthopedic · 98d
Cleared Mar 29, 1983
AMPCO KIDNEY DIALYSIS TRAY
K823839 · KOC
Associated Medical Products Co.
Gastroenterology & Urology · 98d