FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157009–157032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1983
MODEL VPS VASCULAR PROFILE SYSTEM
K837282
Hoffrel Instruments, Inc.
Radiology · 42d
Cleared Apr 22, 1983
X-RAY BEAM FILTER
K837334
Eastman Kodak Company
Radiology · 23d
Cleared Apr 21, 1983
UWE SUN STREAM UWE BERMUDA UWE SUPER NOVA AND UWE BRONZARETTE
K837278
Unterwasser-Electric GmbH
Radiology · 38d
Cleared Apr 21, 1983
LASER PHOTOCOAGULATOR
K837306
Hgm, Inc.
Radiology · 31d
Cleared Apr 21, 1983
NOVO CEREBROGRAPH
K837322
Novo Diagnostic Systems
Radiology · 28d
Cleared Apr 21, 1983
EXOSCOPE LS-53
K837351
Elscint, Inc.
Radiology · 17d
Cleared Apr 21, 1983
POWERED MOBILE BASE FOR 200MM AND 300MM SIZE DETECTORS
K837354
General Electric Co.
Radiology · 17d
Cleared Apr 19, 1983
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
K830004 · JDI
Depuy, Inc.
Orthopedic · 106d
Cleared Apr 18, 1983
NUCLIPASE (I125) PANCREATIC LIPASE
K823860 · CET
Nuclear Diagnostics, Inc.
Chemistry · 117d
Cleared Apr 18, 1983
BED-CHECK: II-IFAC
K823926 · KMI
Bed-Check Corp.
General Hospital · 110d
Cleared Apr 18, 1983
DISPOSABLE PRESSURE TRANSDUCER
K830210 · DRS
American Pharmaseal Div. Ahsc
Cardiovascular · 84d
Cleared Apr 18, 1983
PROTOPORPHYRIN ZN CONTROL
K830493 · JJX
Kaulson Laboratories, Inc.
Toxicology · 61d
Cleared Apr 18, 1983
PRIVATE LABE/ DEODORANT MAXIPAD
K830630 · HHL
Int'L Consumer Disposables
Obstetrics & Gynecology · 48d
Cleared Apr 18, 1983
PHYSIOLOGICAL PRESSURE MEASUREMENT SYS
K830638 · DXO
Camino Laboratories, Inc.
Cardiovascular · 48d
Cleared Apr 18, 1983
FORGARTY CHIN PERIPHERAL INTRAOPERATIVE
K830733 · LIT
American Edwards Laboratories
Cardiovascular · 41d
Cleared Apr 18, 1983
WAKO FREE CHOLESTEROL C TEST
K830761 · CHH
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared Apr 18, 1983
TEMP. PACING LEAD, BIPOLAR #TH60, 90/110
K830772 · LDF
Oscor, Inc.
Cardiovascular · 38d
Cleared Apr 18, 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · DTB
Intermedics, Inc.
Cardiovascular · 38d
Cleared Apr 18, 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · DHR
Emd Chemicals, Inc.
Immunology · 33d
Cleared Apr 18, 1983
Q.C. TESTER
K830836 · LHI
Alltek Filtration, Inc.
Microbiology · 27d
Cleared Apr 18, 1983
IMMO PHASE DIRECT PROGESTERONE RADIO-
K830880 · JLS
Corning Medical & Scientific
Chemistry · 31d
Cleared Apr 18, 1983
HUMIDIFIER, WITH OR WITHOUT ADAPTER
K830896 · KFZ
Airlife, Inc.
Anesthesiology · 28d
Cleared Apr 18, 1983
UPTAKE T3 RADIOIMMUNOASSAY KIT
K830900 · KHQ
Medical & Scientific Designs, Inc.
Chemistry · 28d
Cleared Apr 18, 1983
MIKRO-TIP CATH. PRESSURE TRANSDUCER
K830909 · KRB
Millar Instruments, Inc.
Cardiovascular · 28d