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
95137–95160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE...
K964010 · MSJ
Beckman Instruments, Inc.
Immunology · 126d
Cleared Feb 10, 1997
MINERAL TRIOXIDE AGGREGATE (MTA)
K964174 · KIF
Tulsa Dental Products, Ltd.
Dental · 115d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE...
K964260 · DFH
Beckman Instruments, Inc.
Immunology · 108d
Cleared Feb 10, 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372 · MMI
Boehringer Mannheim Corp.
Chemistry · 101d
Cleared Feb 10, 1997
PARASCAN SCANNING DEVICE
K964520 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Feb 10, 1997
RECOVER INFANT HEEL WARMER (5100)
K964523 · MPO
Florida Medical Industries, Inc.
Physical Medicine · 90d
Cleared Feb 10, 1997
LIBERTY RECTAL PELVIC FLOOR EXERCISER
K964526 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 10, 1997
EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 83d
Cleared Feb 10, 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628 · LZA
Shen Wei (Usa), Inc.
General Hospital · 83d
Cleared Feb 10, 1997
VINYL PATIENT EXAMINATION GLOVES
K964629 · LYZ
Arista Medi Prima
General Hospital · 83d
Cleared Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · CGA
Bayer Corp.
Chemistry · 83d
Cleared Feb 10, 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · KXK
North American Scientific, Inc.
Radiology · 82d
Cleared Feb 10, 1997
TEFGEN GUIDED TISSUE MEMBRANE
K964656 · NPK
American Custom Medical, Inc.
Dental · 82d
Cleared Feb 10, 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Feb 10, 1997
DERMADAM
K964810 · EFS
Ultradent Products, Inc.
Dental · 73d