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
89809–89832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125 · KGI
Norland Corp.
Radiology · 126d
Cleared May 20, 1998
DUREX ULTRA COMFORT
K980319 · HIS
London Intl., LLC
Obstetrics & Gynecology · 113d
Cleared May 20, 1998
SKAR-KARE SHEET
K980563 · MDA
Life Medical Sciences, Inc.
General & Plastic Surgery · 96d
Cleared May 20, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K980636 · FFS
Dutch Ophthalmic USA, Inc.
Gastroenterology & Urology · 90d
Cleared May 20, 1998
REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
K980665 · HRY
Biomet, Inc.
Orthopedic · 89d
Cleared May 20, 1998
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
K980685 · GEX
Lumenis, Inc.
General & Plastic Surgery · 86d
Cleared May 20, 1998
RADIOCAMERAS PATIENT POSITIONING SYSTEM
K980750 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 83d
Cleared May 20, 1998
DUAL LOCK HIP STEM
K980794 · JDI
Depuy, Inc.
Orthopedic · 79d
Cleared May 20, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837 · JAK
Shimadzu Medical Systems
Radiology · 77d
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