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
82609–82632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431 · JAK
Shimadzu Medical Systems
Radiology · 84d
Cleared Mar 22, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K994226 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 22, 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
K994339 · KGN
The Hymed Group Corp.
General & Plastic Surgery · 90d
Cleared Mar 22, 2000
M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
K994351 · LNH
Resonance Technology, Inc.
Radiology · 90d
Cleared Mar 22, 2000
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
K994352 · CAF
Hudson Respiratory Care, Inc.
Anesthesiology · 90d
Cleared Mar 22, 2000
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
K994353 · HFM
Precision Dynamics Corp.
Obstetrics & Gynecology · 90d
Cleared Mar 22, 2000
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
K994355 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
K000038 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
K000039 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
K000040 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 75d
Cleared Mar 21, 2000
HARDYDISK, KANAMYCIN, 30MCG
K000203 · JTN
Hardy Diagnostics
Microbiology · 60d
Cleared Mar 21, 2000
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
K000229 · FCW
Videolabs, Inc.
Gastroenterology & Urology · 54d
Cleared Mar 21, 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
K000239 · LCP
Genzyme Corp.
Hematology · 54d
Cleared Mar 21, 2000
HARDYDISK, CIPROFLOXACIN, 5MCG
K000258 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
HARDYDISK, CEFTAZIDIME, 30MCG
K000259 · JTN
Hardy Diagnostics
Microbiology · 53d
Cleared Mar 21, 2000
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY...
K000376 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared Mar 21, 2000
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT...
K000529 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 33d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Mar 21, 2000
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
K000728 · FST
Medtronic Xomed
General & Plastic Surgery · 15d
Cleared Mar 21, 2000
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · DQK
Premier Heart, LLC
Cardiovascular · 222d
Cleared Mar 21, 2000
OVES CERVICAL CAP
K993953 · HDR
Veos , Ltd.
Obstetrics & Gynecology · 120d
Cleared Mar 21, 2000
MALE LATEX CONDOM WITH VANILLA FLAVOR
K994311 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Mar 21, 2000
MALE LATEX CONDOM 56MM
K994312 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317 · KXK
Implant Sciences Corp.
Radiology · 90d