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
78313–78336 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · LTT
Dade Behring, Inc.
Microbiology · 191d
Cleared Aug 22, 2001
CRYOPLAN SYSTEM
K011073 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 135d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Aug 22, 2001
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749 · LYY
Sempermed USA, Inc.
General Hospital · 83d
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 72d
Cleared Aug 22, 2001
BRIDGE FX
K011817 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 72d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · NEU
Encore Orthopedics, Inc.
General & Plastic Surgery · 70d
Cleared Aug 22, 2001
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
K011941 · FRO
The Kendall Company
General & Plastic Surgery · 62d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · GEI
Ortho Development Corp.
General & Plastic Surgery · 44d
Cleared Aug 22, 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 67d
Cleared Aug 22, 2001
JEL-20
K012303 · EJS
J.F. Jelenko & Co., Inc.
Dental · 33d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Sulzer Spine-Tech
Orthopedic · 30d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Aug 22, 2001
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
K012533 · DQA
Osi Medical, Inc.
Anesthesiology · 16d
Cleared Aug 22, 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · DZE
Straumann USA
Dental · 5d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 159d
Cleared Aug 21, 2001
WECK CARDIAC PACING WIRES
K011660 · LDF
Weck Closure Systems
Cardiovascular · 84d
Cleared Aug 21, 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · DXT
Medrad, Inc.
Cardiovascular · 56d
Cleared Aug 21, 2001
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
K012020 · DQK
Non-Invasive Monitoring Systems, Inc.
Cardiovascular · 54d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038 · KNK
Jas Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 21, 2001
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
K012104 · KGO
Beijing Reagent Latex Products Co., Ltd.
General Hospital · 47d
Cleared Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
K012422 · GGC
Kamiya Biomedical Co.
Hematology · 22d
Cleared Aug 20, 2001
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · MBF
Biomet, Inc.
Orthopedic · 171d
Cleared Aug 20, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · LGD
Bayer Corp.
Microbiology · 160d