FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89089–89112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1998
WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF)
K982364 · HAW
Radionics, Inc.
Neurology · 30d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · JJX
Dade Behring, Inc.
Chemistry · 12d
Cleared Aug 04, 1998
NASAL INTERFACE MODEL 7910
K974453 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 252d
Cleared Aug 04, 1998
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
K974648 · MOP
Sulzer Carbomedics, Inc.
Cardiovascular · 235d
Cleared Aug 04, 1998
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
K980197 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 196d
Cleared Aug 04, 1998
DIVAN ANESTHESIA VENTILATOR
K980208 · CBK
Draeger Medical, Inc.
Anesthesiology · 196d
Cleared Aug 04, 1998
NARKOMED 6000 MODEL NUMBER NM6000
K980553 · BSZ
Draeger Medical, Inc.
Anesthesiology · 173d
Cleared Aug 04, 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761 · MNH
Synthes Spine
Orthopedic · 158d
Cleared Aug 04, 1998
FLO-THRU
K981624 · DXC
Bio-Vascular, Inc.
Cardiovascular · 89d
Cleared Aug 04, 1998
ANGIOLAZ VES-1CAM
K981819 · FWF
Angiolaz, Inc.
General & Plastic Surgery · 74d
Cleared Aug 04, 1998
V.F.I.-VISCOUS FLUID INFUSION TUBING SET
K981907 · MRH
Peregrine Surgical , Ltd.
Ophthalmic · 64d
Cleared Aug 04, 1998
ANTAGON PORCELAIN
K982129 · EIH
European Dental Imports, Inc.
Dental · 48d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES
K980106 · EIA
Proma, Inc.
Dental · 203d
Cleared Aug 03, 1998
ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
K981181 · CHH
Actimed Laboratories, Inc.
Chemistry · 124d
Cleared Aug 03, 1998
DIRECT HDL
K981224 · LBS
Abbott Laboratories
Chemistry · 122d
Cleared Aug 03, 1998
DIRECT LDL
K981303 · MRR
Abbott Laboratories
Chemistry · 115d
Cleared Aug 03, 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · FRN
Alexander Mfg. Co.
General Hospital · 75d
Cleared Aug 03, 1998
ORTHOVU-1000
K981898 · LNH
Magnevu
Radiology · 63d
Cleared Aug 03, 1998
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE
K982015 · LYZ
Taian Plastics Products (Jingxing)...
General Hospital · 56d
Cleared Aug 03, 1998
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K982257 · LYZ
Taian Plastics Products (Jingxing)...
General Hospital · 38d
Cleared Aug 03, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K982284 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 34d
Cleared Aug 03, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K982285 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 34d