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
94609–94632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 10, 1997
EVERT-IT
K962828 · HGY
Genesis Industries, Inc.
Obstetrics & Gynecology · 206d
Cleared Feb 10, 1997
HEARTPORT ENDOVENOUS DRAINAGE CANNULA
K962835 · DWF
Heartport, Inc.
Cardiovascular · 203d
Cleared Feb 10, 1997
PROTEC (1024)
K963730 · KPS
Proportional Technologies, Inc.
Radiology · 147d
Cleared Feb 10, 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · LZA
Hartalega Sdn Bhd
General Hospital · 140d
Cleared Feb 10, 1997
SHARPS CONTAINER MODEL# SC001
K963830 · FMI
Image Medical, Inc.
General Hospital · 139d
Cleared Feb 10, 1997
SHEATHES (NON-LATEX)
K963831 · ITX
Medical Resources
Radiology · 139d
Cleared Feb 10, 1997
AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
K963866 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 210d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · DEW
Beckman Instruments, Inc.
Immunology · 137d
Cleared Feb 10, 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · CFR
Bayer Corp.
Chemistry · 126d