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
95113–95136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1997
TRACH CARE SET WITH MICROBAN
K964369 · BSY
Ballard Medical Products
Anesthesiology · 102d
Cleared Feb 11, 1997
ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
K964461 · JHI
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · JHI
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · JHI
Teco Diagnostics
Chemistry · 91d
Cleared Feb 11, 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544 · MNH
Osteonics Corp.
Orthopedic · 90d
Cleared Feb 11, 1997
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR...
K964561 · FDG
Bioenterics Corp.
Gastroenterology & Urology · 90d
Cleared Feb 11, 1997
SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO,...
K964657 · ESD
Micro-Ear Technology, Inc.
Ear, Nose, Throat · 83d
Cleared Feb 11, 1997
PHASED ARRAY NECK COIL
K964678 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 82d
Cleared Feb 11, 1997
AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
K964697 · DXN
Advance Medical Device, Inc.
Cardiovascular · 81d
Cleared Feb 11, 1997
THE NOMOS MINICRANE
K964740 · JAI
Nomos Corp.
Radiology · 77d
Cleared Feb 11, 1997
MATRIX 3000 FLEXIBLE SPINE COIL
K964753 · LNH
Us Asia Instruments, Inc.
Radiology · 76d
Cleared Feb 11, 1997
UNIVISION ECHOCARDIOLOGY SYSTEM
K964803 · LMB
Network Concepts, Inc.
Radiology · 74d
Cleared Feb 11, 1997
BEAM BLOCK TRAYS
K964840 · IYE
Aktina Medical Physics Corp.
Radiology · 74d
Cleared Feb 11, 1997
MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
K964854 · MOS
Medrad, Inc.
Radiology · 70d
Cleared Feb 11, 1997
BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
K964858 · MMK
Bemis Mfg. Co.
General Hospital · 69d
Cleared Feb 11, 1997
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
K970248 · JQE
Canyon Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 10, 1997
ANTI-VIMENTIN PRIMARY ANTIBODY
K941397 · DEH
Ventana Medical Systems, Inc.
Immunology · 1056d
Cleared Feb 10, 1997
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
K941516 · DEH
Ventana Medical Systems, Inc.
Immunology · 1049d
Cleared Feb 10, 1997
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K946279 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 776d
Cleared Feb 10, 1997
GAMMA GUIDANCE SYSTEM
K961321 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 311d
Cleared Feb 10, 1997
CVP POLYURETHANE CATHETER
K961552 · FOZ
Abbott Laboratories
General Hospital · 294d
Cleared Feb 10, 1997
FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
K961974 · ITX
Pentax Precision Instrument Corp.
Radiology · 266d
Cleared Feb 10, 1997
OMNICAN SYRINGE
K962084 · FMF
B. Braun Medical AG
General Hospital · 257d
Cleared Feb 10, 1997
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K962576 · DZE
Calcitek, Inc.
Dental · 224d