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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89305–89328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1998
RCI FIXATION SCREWS
K980841 · HWC
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 20, 1998
COPPER TONGUE SCRAPER
K980842 · LCN
Ontel Products Corp.
Dental · 77d
Cleared May 20, 1998
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
K980861 · MGQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 76d
Cleared May 20, 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · MNH
United States Surgical, A Division of...
Orthopedic · 76d
Cleared May 20, 1998
MEDI-DX 7000 CPT WITH AMREX ELECTRODES
K980866 · GWF
Neuro-Diagnostic Assoc.
Neurology · 90d
Cleared May 20, 1998
SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)
K980880 · KGO
Ansell Perry
General Hospital · 72d
Cleared May 20, 1998
OMEGA HA COATED TOTAL HIP SYSTEM
K980981 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 64d
Cleared May 20, 1998
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · ETB
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 61d
Cleared May 20, 1998
20-HOLE ADAPTATION PLATE
K981070 · JEY
Biomet, Inc.
Dental · 57d
Cleared May 20, 1998
DYONICS INTELIJET INFLOW/OUTFLOW CANNULA
K981156 · HRX
Smith & Nephew, Inc.
Orthopedic · 50d
Cleared May 20, 1998
ELECTROSURGICAL CAUTERY PROBES
K981188 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 48d
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · CJE
Abbott Laboratories
Chemistry · 44d
Cleared May 20, 1998
TIBC
K981279 · JMO
Abbott Laboratories
Chemistry · 42d
Cleared May 20, 1998
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
K981404 · IYO
Fukuda Denshi USA, Inc.
Radiology · 33d
Cleared May 20, 1998
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
K981407 · LIT
Cordis Corp.
Cardiovascular · 30d
Cleared May 20, 1998
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
K981423 · JEC
Autogenesis, Inc.
Orthopedic · 30d
Cleared May 20, 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452 · KWP
Osteonics Corp.
Orthopedic · 28d
Cleared May 20, 1998
KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND...
K981458 · EOB
Karl Storz Endoscopy
Ear, Nose, Throat · 27d
Cleared May 20, 1998
CUB DIS II DPOAE MEASUREMENT SYSTEM
K981460 · EWO
Mimosa Acoustics, Inc.
Ear, Nose, Throat · 27d
Cleared May 19, 1998
CRISTOBAL
K980018 · EBF
Newave Medical, Inc.
Dental · 137d
Cleared May 19, 1998
CATARACT LIQUEFRACTURE DEVICE
K980292 · MUS
Alcon Laboratories
Ophthalmic · 113d
Cleared May 19, 1998
OPHTHAVISION IMAGING SYSTEM
K980295 · HKI
Mrp Group, Inc.
Ophthalmic · 112d
Cleared May 19, 1998
SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
K980604 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 91d
Cleared May 19, 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d