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
97465–97488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 1996
HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS...
K955087 · LCP
Bayer Corp.
Hematology · 219d
Cleared Jun 13, 1996
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 198d
Cleared Jun 13, 1996
RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP,...
K960591 · IKT
Chalgren Enterprises, Inc.
Neurology · 122d
Cleared Jun 13, 1996
SYNERGY PLUS
K960762 · HCC
The Prometheus Group
Neurology · 108d
Cleared Jun 13, 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213 · KTT
Howmedica Corp.
Orthopedic · 77d
Cleared Jun 13, 1996
NEUROVIEW SCISSORS
K961406 · GWG
Neuro Navigational Corp.
Neurology · 63d
Cleared Jun 13, 1996
ELECSYS T4 ASSAY
K961490 · CDX
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 13, 1996
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
K961620 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
K961659 · JIX
Boehringer Mannheim Corp.
Toxicology · 44d
Cleared Jun 13, 1996
ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
K961662 · KMF
Mariner Biomedical, Inc.
General & Plastic Surgery · 44d
Cleared Jun 13, 1996
CEMENT AND BONE REMOVAL KIT
K961759 · HWE
Maillefer Instruments S.A.
Orthopedic · 37d
Cleared Jun 13, 1996
SUPPLE PERI-GUARD PERICARDIUM
K961810 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 34d
Cleared Jun 13, 1996
PERI-GUARD PERICARDIUM
K961811 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 34d
Cleared Jun 13, 1996
ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES
K961812 · GEI
Conmedcorp
General & Plastic Surgery · 34d
Cleared Jun 12, 1996
ESI-5000
K935024 · IYN
Elscint, Inc.
Radiology · 966d
Cleared Jun 12, 1996
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680 · JIN
Polymer Technology Intl.
Chemistry · 310d
Cleared Jun 12, 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · KQO
Bayer Corp.
Chemistry · 125d
Cleared Jun 12, 1996
SPINAL TOUCH
K961212 · KQX
Fasstech
Neurology · 76d
Cleared Jun 12, 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP,...
K961325 · JXM
Princeton BioMeditech Corp.
Toxicology · 65d
Cleared Jun 12, 1996
TRICYCLICS SERUM TOX ASSAY
K961393 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Jun 12, 1996
PORTA'PURE/DENTAL
K961409 · EIA
Water Solution Technologies
Dental · 62d
Cleared Jun 12, 1996
AVL 9180 ELECTROLYTE ANALYZER
K961458 · JFP
Avl Scientific Corp.
Chemistry · 58d
Cleared Jun 12, 1996
ELECSYS HCG ASSAY
K961487 · DHA
Boehringer Mannheim Corp.
Chemistry · 55d
Cleared Jun 12, 1996
ELECSYS T-UPTAKE ASSAY
K961488 · KHQ
Boehringer Mannheim Corp.
Chemistry · 55d