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
68281–68304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2004
BAHA DIVINO
K042017 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 26, 2004
INNOVA 4100, INNOVA 3100
K042053 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Aug 26, 2004
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
K042061 · NGT
Becton Dickinson
General Hospital · 24d
Cleared Aug 26, 2004
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K042121 · FRN
Sigma Intl.
General Hospital · 20d
Cleared Aug 26, 2004
3.0T 8-CHANNEL CTL SPINE ARRAY
K042186 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Aug 26, 2004
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL
K042207 · MOS
Usa Instruments, Inc.
Radiology · 10d
Cleared Aug 25, 2004
5000Z SYSTEM (OTC)
K033122 · NUH
Prizm Medical, Inc.
Neurology · 330d
Cleared Aug 25, 2004
BICONTACT HIP STEM AND FEMORAL HEAD
K040191 · LPH
Aesculap
Orthopedic · 210d
Cleared Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · LZO
Howmedica Osteonics Corp.
Orthopedic · 156d
Cleared Aug 25, 2004
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30,...
K041451 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 85d
Cleared Aug 25, 2004
SNAP-OFF SCREWS
K041456 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Aug 25, 2004
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S
K041573 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 72d
Cleared Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · MQV
Novabone Products, LLC
Orthopedic · 71d
Cleared Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616 · MQV
Orthos (Uk) Limited
Orthopedic · 71d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1...
K041720 · MRR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 62d
Cleared Aug 25, 2004
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR...
K041799 · NQD
Ortho-Clinical Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 25, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · PHX
Tornier
Orthopedic · 44d
Cleared Aug 25, 2004
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
K042023 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 28d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Aug 25, 2004
KLSA MARTIN HAND DISTRACTOR
K042066 · JEC
KLS-Martin L.P.
Orthopedic · 23d
Cleared Aug 24, 2004
TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
K032291 · DOA
Linde Medical Sensors AG
Toxicology · 397d
Cleared Aug 24, 2004
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · DSK
Schiller AG
Cardiovascular · 270d
Cleared Aug 24, 2004
PIESOMETER, MODEL MK-1
K041169 · DXN
Canamet Canadian Natl Medical...
Cardiovascular · 112d
Cleared Aug 24, 2004
FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01
K041400 · DXN
Fortifier International Co., Ltd.
Cardiovascular · 90d