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
94633–94656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 10, 1997
NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
K964812 · FPA
Critical Device Corp.
General Hospital · 73d
Cleared Feb 10, 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 68d
Cleared Feb 10, 1997
TROPONIN-I TEST SYSTEM
K964862 · MMI
Dade Intl., Inc.
Chemistry · 68d
Cleared Feb 10, 1997
WHITE CORE
K964931 · EBF
Bisco, Inc.
Dental · 62d
Cleared Feb 10, 1997
ROUND DENTAL BUR
K964944 · DZE
Steri-Oss, Inc.
Dental · 62d
Cleared Feb 10, 1997
TEMPFIL C&B
K964981 · EBG
Sybron Dental Specialties, Inc.
Dental · 60d
Cleared Feb 10, 1997
PFINGST PRESSURE PASTE
K965026 · EFH
Pfingst & Co., Inc.
Dental · 55d
Cleared Feb 10, 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Feb 10, 1997
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213 · DDR
Dade Intl., Inc.
Immunology · 42d