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
158881–158904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K823778 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Jan 07, 1983
ELASTIC COMPRESSION ANKLET
K823789 · FQL
Orthopaedic Resources Corp.
General Hospital · 22d
Cleared Jan 07, 1983
AZLOCILLIN 75MCG SENSI-DISC
K823800 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 07, 1983
LASER PHOTOCOAGULATOR
K827819
American Laser Corp.
Radiology · 80d
Cleared Jan 06, 1983
MODEL 716 MICROMANIPULATOR
K828056
Laser Industries , Ltd.
Radiology · 31d
Cleared Jan 05, 1983
LENS
K821897 · KYG
Mortan, Inc.
Ophthalmic · 191d
Cleared Jan 05, 1983
COHERENT FUNDUSL RETINAL CAMERA
K822908 · HKI
Coherent Medical Division
Ophthalmic · 97d
Cleared Jan 05, 1983
BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.
K823273 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 64d
Cleared Jan 05, 1983
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359 · DRY
Bentley Laboratories, Inc.
Cardiovascular · 61d
Cleared Jan 05, 1983
PROFESSIONAL MARK I BIOFEEDBACK SYS
K823381 · HCC
Srs Co.
Neurology · 54d
Cleared Jan 05, 1983
RESPIRATORY GAS ANALYZER
K823449 · CCL
Thoratec Laboratories Corp.
Anesthesiology · 54d
Cleared Jan 05, 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 05, 1983
STOCK #64091-PEDIATRIC OXYGEN MASK
K823532 · BYG
B & F Medical Products, Inc.
Anesthesiology · 37d
Cleared Jan 05, 1983
CORCATH H & B VASCULAR ACCESS CATHETER
K823553 · LJS
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 35d
Cleared Jan 05, 1983
ACOH WELLNESS TESTER
K823554 · EWO
Occupational Health, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 05, 1983
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
K823555 · BZK
Penlon, Inc.
Anesthesiology · 35d
Cleared Jan 05, 1983
OXYGEN CONCENTRATOR UCC-100
K823582 · CAW
Linde Div. Union Carbide Corp.
Anesthesiology · 30d
Cleared Jan 05, 1983
UNI-CELL
K823587 · GLQ
Medical Specialties Laboratories
Hematology · 30d
Cleared Jan 05, 1983
FRONING GUIDANCE SYSTEM #TX-8200
K823675 · HAW
Today'S Machining & Design, Inc.
Neurology · 29d
Cleared Jan 05, 1983
COAT-A-COUNT MORPHINE KIT & COMPONENTS
K823680 · DDE
Diagnostic Products Corp.
Chemistry · 29d
Cleared Jan 05, 1983
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO
K823688 · JLW
Corning Medical & Scientific
Chemistry · 29d
Cleared Jan 05, 1983
PREP TYPE A EXTRACTION CARTRIDGE
K823697 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Jan 05, 1983
HOSPAL BLOOD LINES
K823707 · KOC
Hospal Medical Corp.
Gastroenterology & Urology · 27d
Cleared Jan 05, 1983
AML (ANGLE MAGNIFYING LENS
K823719 · HKI
Nikon, Inc.
Ophthalmic · 26d