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
79249–79272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2001
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
K012094 · MWI
Agilent Technologies, Inc.
Cardiovascular · 15d
Cleared Jul 20, 2001
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
K012107 · LCM
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Jul 20, 2001
LIVESURE BENZODIAZEPINES SCREEN TESTS
K012131 · JXM
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
LIVESURE BARBITURATES SCREEN TEST
K012133 · DIS
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · DXQ
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 7d
Cleared Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
K983332 · LHN
Massachusetts General Hospital
Radiology · 1032d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075,...
K004003 · MQV
Interpore Cross Intl.
Orthopedic · 206d
Cleared Jul 19, 2001
SPLITTABLE SHEATH INTRODUCER KIT
K004025 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 204d
Cleared Jul 19, 2001
ENTEC EVAC PLASMA WAND
K011279 · GEI
Arthrocare Corp.
General & Plastic Surgery · 83d
Cleared Jul 19, 2001
INFINION ENHANCEMENT PACKAGE
K011296 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 80d
Cleared Jul 19, 2001
MTP LAPAROMAT DISPOSABLE TUBING SET
K011360 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 77d
Cleared Jul 19, 2001
CAVEX STABISIL
K011452 · ELW
Cavex Holland BV
Dental · 69d
Cleared Jul 19, 2001
ENDOPOUCH RETRIEVER
K011501 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 64d
Cleared Jul 19, 2001
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · LBI
Ohmeda Medical
General Hospital · 62d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 19, 2001
CASCADE BATH, MODEL 6900
K012057 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 17d
Cleared Jul 19, 2001
SUPERIOR BATH, MODEL 6300
K012061 · ILJ
Penner Manufacturing, Inc.
Physical Medicine · 17d
Cleared Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 264d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
United States Surgical, A Division of...
Orthopedic · 229d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · KWP
Depuyacromed
Orthopedic · 133d
Cleared Jul 18, 2001
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
K011206 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 18, 2001
PVC FREE INTRAVASCULAR ADMINISTRATION SET
K011216 · FPA
Biometrix , Ltd.
General Hospital · 89d
Cleared Jul 18, 2001
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312 · CBF
Khrunichev State Research &...
Anesthesiology · 79d